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


臨床試験数 : 113 薬物数 : 111 - (DrugBank : 26) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 102

  
17 trials found
No.TrialIDDate_
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1ChiCTR2100046551
2021-05-182021-05-21Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatmentApplication of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome Prader-Willi sydromePrader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none;Cai JinhuaNULLRecruiting016BothPrader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40;N/AChina
2JPRN-jRCT2031200351
09/02/202108/02/2021Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWSA 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 SyndromeBiological: 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
Kawai NorisukeNULLNot Recruiting>=Not applicableBoth30Phase 3Japan
3NCT04697381
(ClinicalTrials.gov)
February 6, 20214/1/2021Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWSA 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 SyndromeBiological: somatropin - GH naïve pediatric cohort;Biological: somatropin - GH treated cohort;Biological: somatropin - adult cohortPfizerNULLActive, not recruiting0 YearsN/AAll32Phase 3Japan
4ChiCTR1900027464
2019-12-012019-11-14Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone ageEfficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age Prader-Willi syndromecontrol group:Single rhGH therapy;observation group:Anastrazole combined with growth hormone therapy;Children's Hospital of Zhejiang University School of MedicineNULLPendingMalecontrol group:20;observation group:20;Phase 4China
5ChiCTR1900022809
2019-05-012019-04-26Efficacy and safety of growth hormone in the treatment of Prader-Willi syndromeEfficacy and safety of growth hormone in the treatment of Prader-Willi syndrome Prader-Willi syndromecontrol group:Routine treatment such as rehabilitation;Treated group:treatment with growth hormone;Children's Hospital of Zhejiang University School of MedicineNULLPendingBothcontrol group:20;Treated group:50;N/AChina
6NCT03554031
(ClinicalTrials.gov)
April 14, 201830/5/2018A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromeA Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: Recombinant Human Growth Hormone (rhGH) InjectionGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of MedicineUnknown status1 Month5 YearsAll30Phase 3China
7EUCTR2017-002164-41-ES
(EUCTR)
03/07/201721/06/2017Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures.Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition. Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit.
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: Genotonorm Miniquick 0,2 mg
INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Spain
8NCT03616509
(ClinicalTrials.gov)
June 19, 201727/7/2018GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body CompositionTreatment With Growth Hormone in Adults With PWS, Effect on Muscular Tone Evaluated by Functional MRI, Relationship With Strength and Body CompositionPrader-Willi SyndromeDrug: Growth hormone;Drug: PlaceboCorporacion Parc TauliParc de Salut MarCompleted18 YearsN/AAll30Phase 4Spain
9NCT02205450
(ClinicalTrials.gov)
September 201430/7/2014Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of SabadellExperience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of SabadellPrader-Willi SyndromeDrug: Recombinant SomatropinCorporacion Parc TauliNULLNot yet recruitingN/A2 YearsBoth15N/ASpain
10EUCTR2011-001313-14-NL
(EUCTR)
17/10/201212/01/2012Young 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 foundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
11NCT01401244
(ClinicalTrials.gov)
July 14, 201120/7/2011Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult VolunteersA Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult VolunteersGenetic Disorder;Prader-Willi Syndrome;Growth Disorder;Idiopathic Short Stature;HealthyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years40 YearsAll30Phase 1United States
12NCT01298180
(ClinicalTrials.gov)
January 20096/11/2009Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?Prader-Willi Syndrome;Growth Hormone DeficiencyDrug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsyUniversity Hospital, ToulouseNULLCompleted1 Year5 YearsAll111Phase 4France
13NCT00705172
(ClinicalTrials.gov)
November 200824/6/2008Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi SyndromeEfficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS)Genetic Disorder;Prader-Willi SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/A15 YearsBoth41N/ADenmark;Germany;Switzerland
14EUCTR2007-004716-31-NL
(EUCTR)
05/03/200806/11/2007Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWSEffects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS Prader-Willi Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome
Trade Name: GenotropinDutch Growth FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
15EUCTR2007-000469-39-FI
(EUCTR)
02/05/200712/02/2007An 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. - NAAn 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 AbNULLNot RecruitingFemale: yes
Male: yes
Phase 4Finland
16NCT00444964
(ClinicalTrials.gov)
April 20056/3/2007Growth Hormone Use in Adults With Prader-Willi SyndromeGrowth Hormone Use in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Nutropin AQChildren's Mercy Hospital Kansas CityNULLRecruiting16 Years60 YearsBoth10Phase 3United States
17NCT00372125
(ClinicalTrials.gov)
April 20055/9/2006Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi SyndromeNordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Norditropin SimpleXxKarolinska University HospitalNovo Nordisk A/SCompleted18 Years50 YearsBoth46N/ADenmark;Norway;Sweden