226. 間質性膀胱炎（ハンナ型） Interstitial cystitis with Hunners ulcer Clinical trials / Disease details
臨床試験数 : 145 / 薬物数 : 156 - (DrugBank : 51) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 146
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01197261 (ClinicalTrials.gov) | September 2010 | 7/9/2010 | OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS) | An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome. | Interstitial Cystitis;Painful Bladder Syndrome;Pain | Drug: Oxycodone naloxone prolonged release tablets;Drug: Placebo tablets | Mundipharma Research GmbH & Co KG | NULL | Completed | 18 Years | N/A | Female | 120 | Phase 2 | Czechia;Germany;Hungary;Poland;United Kingdom;Czech Republic |
| 2 | EUCTR2009-018118-21-CZ (EUCTR) | 09/08/2010 | 10/06/2010 | not applicable | An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable | Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome) MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg Product Code: OXN 5/2.5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg Product Code: OXN 10/5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 20mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg Product Code: OXN 20/10 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release t | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: no | 70 | Hungary;Czech Republic;Germany;United Kingdom | |||
| 3 | EUCTR2009-018118-21-HU (EUCTR) | 04/08/2010 | 21/05/2010 | not applicable | An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable | Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome) MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg Product Code: OXN 5/2.5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg Product Code: OXN 10/5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 20mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg Product Code: OXN 20/10 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release t | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: no | 70 | Czech Republic;Hungary;Germany;United Kingdom | |||
| 4 | EUCTR2009-018118-21-GB (EUCTR) | 28/07/2010 | 11/06/2010 | not applicable | An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable | Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome) MedDRA version: 14.0;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg Product Code: OXN 5/2.5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg Product Code: OXN 10/5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 20mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg Product Code: OXN 20/10 mg PR | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: no | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary;Germany;United Kingdom | ||
| 5 | EUCTR2007-005164-27-NL (EUCTR) | 22/02/2008 | 17/10/2007 | Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial Cystitis | Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial Cystitis | Interstitial Cystitis (IC) is a syndrome characterized by bladder pain associated with urgency, frequency, nocturia, dysuria and sterile urine. The patho-physiology remains largely unclear. No universally, effective, treatment exists. Botulinum toxin-A (BTX-A) inhibits the release of acetylcholine at the presynaptic cholinergic junction resulting in temporally muscle relaxation and bladder desensitisation. We explore the effects of intravesical injections with BTX-A in the treatment of IC. | Trade Name: Botox | research office urology VUmc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Netherlands | |||
| 6 | EUCTR2009-018118-21-DE (EUCTR) | 10/05/2010 | not applicable | An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naïve Subjects suffering from severe pain due to Bladder Pain Syndrome. - not applicable | Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome) MedDRA version: 14.1;Level: LLT;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5/2.5 mg Product Code: OXN 5/2.5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10/5 mg Product Code: OXN 10/5 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 20mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20/10 mg Product Code: OXN 20/10 mg PR Other descriptive name: OXYCODONE HYDROCHLORIDE Other descriptive name: NALOXONE HYDROCHLORIDE Trade Name: Targinact 5mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release t | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: no | 70 | Czech Republic;Hungary;Germany;United Kingdom |