ETORICOXIB ( DrugBank: Etoricoxib )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ15
271強直性脊椎炎16

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-019871-31-CZ
(EUCTR)
10/05/201101/03/2011Etoricoxib and placebo in patients with rheumatoid arthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisRandomizovaná dvojite zaslepená placebem kontrolovaná multicentrická studie fáze III složená ze dvou cástí hodnotící relativní úcinnost a toleranci dvou dávek MK-0663/Etoricoxibu u pacientu s revmatoidní artritidou Rheumatoid Arthritis (RA)
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
2EUCTR2010-019871-31-SK
(EUCTR)
02/05/201128/02/2011A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
3EUCTR2010-019871-31-BE
(EUCTR)
11/01/201131/08/2010A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
4EUCTR2010-019871-31-GB
(EUCTR)
01/12/201008/10/2010A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,NULLNot Recruiting Female: yes
Male: yes
1800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
5EUCTR2010-019871-31-AT
(EUCTR)
03/11/201001/09/2010Etoricoxib and placebo in patients with rheumatoid arthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
6EUCTR2010-019871-31-LT
(EUCTR)
02/11/201017/09/2010Etoricoxib and placebo in patients with rheumatoid arthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
7EUCTR2010-019871-31-DE
(EUCTR)
25/10/201009/12/2010Etoricoxib and placebo in patients with rheumatoid arthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
8EUCTR2010-019871-31-FI
(EUCTR)
18/10/201030/08/2010Etoricoxib and placebo in patients with rheumatoid arthritisA Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
9NCT01208181
(ClinicalTrials.gov)
September 27, 201022/9/2010A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid ArthritisArthritis, RheumatoidDrug: Etoricoxib 60 mg;Drug: Etoricoxib 90 mg;Drug: Placebo to Etoricoxib 60 mg;Drug: Placebo to Etoricoxib 90 mgOrganon and CoNULLCompleted18 YearsN/AAll1404Phase 3Argentina;Austria;Canada;Colombia;Czech Republic;Finland;Germany;Guatemala;India;Lithuania;Mexico;Panama;Peru;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States
10NCT01067430
(ClinicalTrials.gov)
April 201010/2/2010Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Etoricoxib;Drug: DiclofenacNorthumbria Healthcare NHS Foundation TrustNULLWithdrawn18 YearsN/AAll0Phase 4United Kingdom
11NCT04144101
(ClinicalTrials.gov)
March 1, 200728/10/2019Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid ArthritisComparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot StudyRheumatoid ArthritisDrug: Etoricoxib;Drug: AceclofenacChung Shan Medical UniversityNULLCompleted20 Years80 YearsAll40Phase 4NULL
12NCT01685424
(ClinicalTrials.gov)
June 30, 200623/8/2012Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated AnalysisOsteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;ArthritisDrug: EtoricoxibOrganon and CoNULLCompletedN/AN/AAll79189United States
13NCT00264147
(ClinicalTrials.gov)
January 20069/12/2005Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: etoricoxib;Drug: Comparator: placebo;Drug: Comparator: diclofenacOrganon and CoNULLCompleted18 YearsN/AAll761Phase 2Canada;Colombia;Puerto Rico;Switzerland;United States
14NCT00092742
(ClinicalTrials.gov)
February 200323/9/2004Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodiumOrganon and CoNULLCompleted50 YearsN/AAll4086Phase 3United States
15NCT00250445
(ClinicalTrials.gov)
January 20037/11/2005A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid ArthritisRheumatoid Arthritis,OsteoarthritisDrug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodiumOrganon and CoNULLCompleted50 YearsN/AAll23498Phase 3NULL

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-019872-65-LT
(EUCTR)
11/04/201317/01/2013Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosyn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
2EUCTR2010-019872-65-CZ
(EUCTR)
10/05/201103/03/2011Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
3EUCTR2010-019872-65-SK
(EUCTR)
02/05/201128/02/2011A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing SpondylitisA Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ARCOXIA
Product Name: etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: naproxen
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
4NCT01327638
(ClinicalTrials.gov)
February 15, 201111/3/2011Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis PatientsSpondylarthropathies; Spondylitis, AnkylosingDrug: etoricoxib;Drug: Other COX-2 inhibitor;Drug: nsNSAIDsOrganon and CoNULLCompleted16 YearsN/AAll21108NULL
5EUCTR2010-019872-65-AT
(EUCTR)
14/01/201103/09/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
6EUCTR2010-019872-65-BE
(EUCTR)
11/01/201131/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
7EUCTR2010-019872-65-GB
(EUCTR)
01/12/201008/10/2010A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing SpondylitisA Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,NULLNot Recruiting Female: yes
Male: yes
1300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
8EUCTR2010-019872-65-EE
(EUCTR)
29/11/201003/11/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
9EUCTR2010-019872-65-HU
(EUCTR)
09/11/201010/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
10EUCTR2010-019872-65-FI
(EUCTR)
18/10/201030/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
11NCT01208207
(ClinicalTrials.gov)
September 27, 201022/9/2010A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mgOrganon and CoNULLCompleted18 YearsN/AAll1015Phase 3Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States
12NCT01091675
(ClinicalTrials.gov)
September 201022/3/2010Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to =2 NSAIDsAssessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to =2 Nonsteroidal Antiinflammatory Drug (NSAID)Ankylosing SpondylitisDrug: EtoricoxibSpanish Foundation of RheumatologyNULLCompleted18 YearsN/AAll58Phase 3Spain
13EUCTR2009-017309-12-ES
(EUCTR)
18/02/201018/12/2009Evaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINESEvaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINES Espondilitis Anquilosante
MedDRA version: 9;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ARCOXIA 90 mg comprimidos recubiertos con película
INN or Proposed INN: ETORICOXIB
Other descriptive name: ETORICOXIB
FUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA (FER)NULLNot RecruitingFemale: yes
Male: yes
Spain
14NCT01077843
(ClinicalTrials.gov)
August 17, 200926/2/2010Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and GermanyAnkylosing SpondylitisDrug: Etoricoxib;Drug: Other Cox-2 inhibitors;Drug: Other Non-selective NSAIDs;Other: No anti-inflammatory treatmentOrganon and CoNULLCompletedN/AN/AAll27381NULL
15NCT01685424
(ClinicalTrials.gov)
June 30, 200623/8/2012Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated AnalysisOsteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;ArthritisDrug: EtoricoxibOrganon and CoNULLCompletedN/AN/AAll79189United States
16EUCTR2010-019872-65-DE
(EUCTR)
04/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany