193. Prader-Willi syndrome Clinical trials / Disease details
Clinical trials : 111 / Drugs : 120 - (DrugBank : 30) / Drug target genes : 51 - Drug target pathways : 103
| 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 | JPRN-jRCT2031200351 | 09/02/2021 | 08/02/2021 | Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS | A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) - NA | Prader-Willi Syndrome | Biological: somatropin - GH naive pediatric cohort somatropin 0.245 mg/kg/week Biological: somatropin - GH treated cohort somatropin 0.084 mg/kg/week Biological: somatropin - adult cohort somatropin 0.084 mg/kg/week | Nagashima Masahito | NULL | Recruiting | >= | Not applicable | Both | 30 | Phase 3 | Japan |
| 2 | NCT04697381 (ClinicalTrials.gov) | February 9, 2021 | 4/1/2021 | Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS | A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) | Prader-Willi Syndrome | Biological: somatropin - GH naïve pediatric cohort;Biological: somatropin - GH treated cohort;Biological: somatropin - adult cohort | Pfizer | NULL | Active, not recruiting | N/A | N/A | All | 32 | Phase 3 | Japan |
| 3 | NCT04484051 (ClinicalTrials.gov) | October 1, 2020 | 15/7/2020 | Global Growth Hormone Study in Adults With Prader-Willi Syndrome | Global Growth Hormone Study in Adults With Prader-Willi Syndroom | Prader-Willi Syndrome | Drug: Somatropin;Drug: Placebo | Erasmus Medical Center | Pfizer;Foundation for Prader-Willi Research;Prader-Willi Fonds | Not yet recruiting | 30 Years | N/A | All | 50 | Phase 3 | Australia;Netherlands |
| 4 | NCT02205450 (ClinicalTrials.gov) | September 2014 | 30/7/2014 | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | Prader-Willi Syndrome | Drug: Recombinant Somatropin | Corporacion Parc Tauli | NULL | Not yet recruiting | N/A | 2 Years | Both | 15 | N/A | Spain |
| 5 | EUCTR2011-001313-14-NL (EUCTR) | 17/10/2012 | 12/01/2012 | Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. | Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. - Young Adult Prader Willi study | Prader Willi Syndrome MedDRA version: 14.1;Level: LLT;Classification code 10041331;Term: Somatotrophin;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made. Product Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: growth hormone | Dutch growth research foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 6 | NCT01401244 (ClinicalTrials.gov) | July 14, 2011 | 20/7/2011 | Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers | A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers | Genetic Disorder;Prader-Willi Syndrome;Growth Disorder;Idiopathic Short Stature;Healthy | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 40 Years | All | 30 | Phase 1 | United States |
| 7 | NCT00705172 (ClinicalTrials.gov) | November 2008 | 24/6/2008 | Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome | Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS) | Genetic Disorder;Prader-Willi Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 15 Years | Both | 41 | N/A | Denmark;Germany;Switzerland |
| 8 | EUCTR2007-000469-39-FI (EUCTR) | 02/05/2007 | 12/02/2007 | An Open Label Follow-up Study of Patients Who Participated in Clinical Study B9R-HL-GDDV. A Phase IV, one-arm follow-up study to assess final adult results of GH treatment in patients with the Prader-Willi Syndrome. - NA | An Open Label Follow-up Study of Patients Who Participated in Clinical Study B9R-HL-GDDV. A Phase IV, one-arm follow-up study to assess final adult results of GH treatment in patients with the Prader-Willi Syndrome. - NA | Prader-Willi syndrome MedDRA version: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome | Trade Name: Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten INN or Proposed INN: SOMATROPIN | Oy Eli Lilly Finland Ab | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Finland |