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 | EUCTR2016-000906-12-NL (EUCTR) | 15/06/2017 | 19/07/2017 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by a 40-Week Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 19.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 19.1;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857 ;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Netherlands;Germany;Latvia | ||
| 2 | EUCTR2016-000906-12-BE (EUCTR) | 24/04/2017 | 16/01/2017 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000017419 MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000017419;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands | ||
| 3 | EUCTR2016-000906-12-ES (EUCTR) | 02/03/2017 | 16/01/2017 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by a 40-Week Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 19.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 19.1;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Germany;Latvia;Netherlands | ||
| 4 | EUCTR2016-000906-12-GB (EUCTR) | 23/11/2016 | 19/08/2016 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 19.1;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom | ||
| 5 | EUCTR2016-000906-12-LV (EUCTR) | 11/11/2016 | 01/08/2016 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom | ||
| 6 | EUCTR2016-000906-12-CZ (EUCTR) | 07/11/2016 | 27/07/2016 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Romania;Denmark;Netherlands;Latvia;United Kingdom | ||
| 7 | EUCTR2016-000906-12-HU (EUCTR) | 23/09/2016 | 27/07/2016 | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by 14 or 40-Week Extension Periods - The LEADERSHIP 301 Trial | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by 14 or 40-Week Extension Periods - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 19.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Belgium;Poland;Romania;Denmark;Netherlands;Latvia;United Kingdom | ||
| 8 | EUCTR2016-000906-12-DK (EUCTR) | 07/09/2016 | 19/07/2016 | A randomized study comparing Placebo and AQX-1125 in the treatment of subjects with Interstitial Cystitis/Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3 Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period - The LEADERSHIP 301 Trial | Interstitial Cystitis/Bladder Pain Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10071166;Term: Bladder pain syndrome;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10008927;Term: Chronic interstitial cystitis;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Product Code: AQX-1125 INN or Proposed INN: AQX-1125 Other descriptive name: AQX-1125 | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Romania;Denmark;Netherlands;Latvia;United Kingdom | ||
| 9 | NCT02858453 (ClinicalTrials.gov) | July 2016 | 19/4/2016 | Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome | The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the Src Homology 2-containing Inositol-5'-Phosphatase 1 (SHIP1) Pathway in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period | Interstitial Cystitis;Bladder Pain Syndrome;Painful Bladder Syndrome;Chronic Interstitial Cystitis | Drug: AQX-1125 100 mg;Drug: AQX-1125 200 mg;Drug: Placebo | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Unknown status | 18 Years | 80 Years | All | 433 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;Hungary;Latvia;Netherlands;Poland;Romania;Spain;United Kingdom;Czech Republic |
| 10 | NCT01882543 (ClinicalTrials.gov) | June 2013 | 18/6/2013 | Efficacy and Safety of AQX-1125 in IC/BPS | A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway | Interstitial Cystitis;Bladder Pain Syndrome | Drug: AQX-1125;Drug: Placebo | Aquinox Pharmaceuticals (Canada) Inc. | NULL | Completed | 18 Years | 75 Years | Female | 69 | Phase 2 | United States;Canada |