193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details


臨床試験数 : 111 薬物数 : 122 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103

  
22 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-002385-12-NL
(EUCTR)
26/08/202108/09/2020Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndromeOxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome: a study of the safety and efficacy on oral and social skills and, feeding behavior of intranasal administrations of oxytocin vs. placebo (phase iii clinical trial) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLNot RecruitingFemale: yes
Male: yes
48Phase 3France;Belgium;Germany;Netherlands
2EUCTR2019-002385-12-DE
(EUCTR)
07/07/202121/04/2021OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;Belgium;Netherlands;Germany
3NCT04283578
(ClinicalTrials.gov)
March 10, 202019/2/2020Oxytocin Treatment in Neonates and Infants With Prader-Willi SyndromeOxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs PlaceboPrader-Willi SyndromeDrug: OT;Drug: Placebo comparatorUniversity Hospital, ToulouseInternational Clinical Trials Association;Epidemiological and Clinical Research Information NetworkActive, not recruitingN/A92 DaysAll48Phase 3France
4EUCTR2019-002385-12-FR
(EUCTR)
27/08/201912/06/2019OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
5NCT03197662
(ClinicalTrials.gov)
April 11, 201819/6/2017Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi SyndromePhase 2 Study: Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Children and Adolescents With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Intranasal Oxytocin (IN-OXT);Drug: Matched PlaceboMontefiore Medical CenterNULLRecruiting5 Years17 YearsAll50Phase 2United States
6EUCTR2017-003423-30-NL
(EUCTR)
12/12/201704/10/2017Intranasal administration of oxytocin in children with Prader-Willi syndromeRandomized, double-blind, placebo-controlled oxytocin and dose-response trial in children with Prader-Willi syndrome.Effects on social behaviour. Prader-Willi syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Dutch Growth Research FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
33Phase 2;Phase 3Netherlands
7NCT03245762
(ClinicalTrials.gov)
August 1, 20177/8/2017Intranasal Oxytocin for Infants With Prader-Willi SyndromeIntranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 StudyPrader-Willi SyndromeDrug: Oxytocin;Drug: PlaceboUniversity of FloridaPrader-Willi Syndrome AssociationCompletedN/A6 MonthsAll15Phase 1/Phase 2United States
8NCT03081832
(ClinicalTrials.gov)
January 201710/3/2017Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.Long Term Evaluation of Infants Aged From 3 to 4 Years Old Included in the Ancient Study (Repeated Administrations of Oxytocin in Infants With Prader Willi Syndrome Aged From 0 to 6 Months) and Comparison With Not Treated and Age-matched Prader Willi Syndrome Infants (OT2SUITE)Prader-Willi SyndromeDrug: Oxytocin;Other: ControlUniversity Hospital, ToulouseNULLCompleted3 Years4 YearsAll34N/AFrance
9EUCTR2016-003820-22-NL
(EUCTR)
22/12/201612/10/2016Intranasal administration of oxytocin in children with Prader-Willi SyndromeIntranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour. - Intranasal administration of oxytocin in children with PWS Prader-Willi syndrome
MedDRA version: 19.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Dutch Growth Research FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
10NCT03114371
(ClinicalTrials.gov)
November 28, 201610/3/2017Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 YearsEffects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.Prader-Willi SyndromeDrug: Oxytocin;Drug: PlaceboUniversity Hospital, ToulouseNULLCompleted3 Years12 YearsAll40N/AFrance
11EUCTR2016-003273-18-FR
(EUCTR)
14/11/201622/08/2016Oxytocin intranasal administrations in children with Prader-Willi syndrome aged from 3 to 12 years.Effects of intranasal administrations of oxytocin on beahvioural troubles, hyperphagia and social skills in children with Prader-Willi syndrome aged from 3 to 12 years. - OXYJEUNE Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: SyntocinonUniversity Hospital of ToulouseNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France
12NCT02629991
(ClinicalTrials.gov)
October 201518/10/2015Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi SyndromeOxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Intranasal Oxytocin (IN-OXT);Drug: Matched PlaceboMontefiore Medical CenterFoundation for Prader-Willi ResearchUnknown status5 Years18 YearsAll24Phase 2United States
13NCT02013258
(ClinicalTrials.gov)
March 201511/12/2013Oxytocin Trial in Prader-Willi SyndromeOxytocin Trial in Prader-Willi SyndromePrader Willi SyndromeDrug: Intranasal oxytocin;Other: PlaceboUniversity of FloridaNational Institutes of Health (NIH)Completed5 Years11 YearsAll24Phase 1United States
14EUCTR2013-004134-15-NL
(EUCTR)
15/07/201420/03/2014Intranasal administration of oxytocin in children and young-adults with Prader-Willi syndromeIntranasal administration of oxytocin in children and young adults with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled trial. Effects on satiety and food intake, and social behaviour. - Intranasal administration of oxytocin in PWS Prader-Willi syndrome
MedDRA version: 17.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Dutch Growth Research FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
15NCT02804373
(ClinicalTrials.gov)
June 201410/7/2015Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi SyndromeEffects of Intranasal Administration of Oxytocin in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Oxytocin (OXT) continuous;Drug: Placebo;Drug: Placebo continuous;Drug: OxytocinUniversity Hospital, ToulouseNULLCompleted18 Years50 YearsAll50Phase 2/Phase 3France
16NCT02205034
(ClinicalTrials.gov)
May 201322/7/2014Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS InfantsEvaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS InfantsPrader Willi SyndromeDrug: oxytocinUniversity Hospital, ToulouseNULLCompleted1 Month5 MonthsAll18Phase 1/Phase 2France
17NCT01548521
(ClinicalTrials.gov)
July 201130/12/2011Tolerance of Intranasal Administration of OT in Prader-Willi Newborn BabiesTolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies and Effect on Suck and Food Intake.Prader-Willi SyndromeDrug: OxytocinUniversity Hospital, ToulouseNULLCompletedN/A5 MonthsAll5Phase 1/Phase 2France
18NCT01038570
(ClinicalTrials.gov)
June 200916/11/2009Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus PlaceboEvaluation of the Effect of the Oxytocin Administered in Nasal Pulverizing on the Social Skills, the Stress, the Anxiety and the Eating Habits at Grown-up Patients Presenting a Syndrome of Prader-Willi: Pilot StudyPrader Willi SyndromeDrug: Syntocinon®/- Spray;Drug: Physiological serum (Sodium chloride)University Hospital, ToulouseNULLCompleted18 YearsN/AAll24Phase 2France
19EUCTR2019-002385-12-BE
(EUCTR)
06/03/2020OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium
20EUCTR2020-006161-11-FR
(EUCTR)
21/04/2021FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIALLONG -TERM INTERVENTIONAL FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIAL AND COMPARISON WITH AN UNTREATED COHORT OF CHILDREN WITH PRADER-WILLI SYNDROME - OTBB3 Follow-Up Prader-willi syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: oxytocinToulouse University HospitalNULLNAFemale: yes
Male: yes
80Phase 3France
21EUCTR2019-002385-12-IT
(EUCTR)
04/06/2021OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
Product Code: [H01BB02]
INN or Proposed INN: OSSITOCINA
Other descriptive name: Oxytocin
University Hospital ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium;Netherlands;Germany;Italy
22EUCTR2021-000094-91-FR
(EUCTR)
01/04/2021EFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA IN CHILDREN AND ADOLESCENTS WITH PRADER WILLI SYNDROMEEFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA RELATED TO OROPHARYNGO-OESOPHAGEAL DYSMOTILITY TRANSIT IN CHILDREN AND ADOLESCENTS WITH PRADER-WILLI SYNDROME: A PHASE 3 STUDY (DYSMOT) - DYSMOT Prader-Willi Syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: OXYTOCIN
Product Code: H01BB02
Toulouse University HospitalNULLNAFemale: yes
Male: yes
36Phase 3France