Oxycodone/naloxone prolonged release tablets (DrugBank: Oxycodone, Naloxone)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 6 |
| 226 | 間質性膀胱炎（ハンナ型） | 5 |
| 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 | EUCTR2011-002901-31-DE (EUCTR) | 08/03/2012 | 06/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 2 | EUCTR2011-002901-31-HU (EUCTR) | 21/12/2011 | 13/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Czech Republic;Hungary;Spain;Germany;United Kingdom | |||
| 3 | EUCTR2011-002901-31-CZ (EUCTR) | 12/12/2011 | 10/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 4 | EUCTR2011-002901-31-ES (EUCTR) | 30/11/2011 | 05/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Hungary;Czech Republic;Germany;United Kingdom;Spain | |||
| 5 | EUCTR2011-002901-31-GB (EUCTR) | 25/11/2011 | 21/09/2011 | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: Oxycodone hydrochloride INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 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 |
| 6 | NCT01439100 (ClinicalTrials.gov) | October 2011 | 21/9/2011 | A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain | Parkinson's Disease With Severe Pain | Drug: Oxycodone/Naloxone Prolonged Release tablets;Drug: Placebo | Mundipharma Research GmbH & Co KG | NULL | Completed | 25 Years | N/A | Both | 172 | Phase 3 | Czech Republic;Germany;Hungary;Poland;Romania;Spain;United Kingdom |
| 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] | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: no | 70 | Phase 2 | Czech Republic;Hungary;Germany;United Kingdom | |||
| 5 | 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 |