DDrare: Database of Drug Development for Rare Diseases

Searched query = "Prader-Willi syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 1.2 mg ZGN-440 for injectable suspension; 1.8 mg ZGN-440 for injectable suspension; ACOMPLIA 20 mg film-coated tablets; ACTH; AZP-531; Acetylcysteine; Acomplia; Air; Anastrozole; B. lactis B94; Beloranib; Byetta; CBDV; CBDV Compound; Cannabidiol; Cannabidiol Oral Solution; Carbetocin; Chloride; Choline; Coenzyme Q10; D.3.2 Product code where applicable13:; DCCR; DIAZOXIDE CHOLINE; Diazoxide; Diazoxide choline; Diazoxide choline controlled-release tablet; EU/1/06/362/003: 5µg (1 pen); Eutropin; Exenatide; FE 992097; Fluimucil; Fluimucil (acetylcysteine); GENOTONORM; 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.; GLWL-01; Genotonorm; Genotonorm Miniquick 0,2 mg; Genotropin; Growth hormone; Growth hormone (Genotonorm® or Omnitrope®); Guanfacine; Guanfacine extended release (GXR); Human growth hormone; Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten; INN Not yet proposed; Intranasal Oxytocin (IN-OXT); Intranasal carbetocin Dose 1; Intranasal carbetocin Dose 2; Intranasal oxytocin; LIRAGLUTIDE; Liraglutide; Livoletide; METOPROLOL SUCCINATE; Medical Air vs Oxygen; Medical air; Metoprolol; Metoprololsuccinat Orion 25mg; Metoprololsuccinat ”Orion” 25mg; Metyrapone; Norditropin SimpleXx; Nutropin AQ; OMNITROPE; OT; OXYTOCIN; Octreotide; Omnitrope; Other: Control; Other: Low dose (1 mcg) ACTH stimulation test; Other: Overnight metyrapone test; Oxygen; Oxytocin; Oxytocin (OXT) continuous; Physiological serum (Sodium chloride); Pitolisant; Pitolisant oral tablets; Probiotic; Procedure: DEXA, blood tests, H.G.P.O, osseous age.; Procedure: biopsy; R05CB01; RECOMBINANT HUMAN GROWTH HORMON; RECOMBINANT HUMAN GROWTH HORMONE; RM-493; Recombinant Human Growth Hormone (rhGH) Injection; Recombinant Somatropin; Recombinant human growth hormone; RhGH; Rimonabant; SOMATROPIN; Sandostatin LAR; Saxenda; Sodium chloride; Somatropin; Subcutaneous Beloranib in Suspension; Syntocinon; Syntocinon nasal spray; Syntocinon®/- Spray; TESOFENSINE; Tesofensine; Tesofensine/Metoprolol; Topiramate; ZGN-440; ZGN-440 for Injectable Suspension; ZGN-440 sterile diluent; [AZP-531]

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	NCT02204163 (ClinicalTrials.gov)	June 2014	25/7/2014	Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome	A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi Syndrome	Prader-Willi Syndrome	Drug: Eutropin;Drug: Genotropin	LG Life Sciences	NULL	Completed	N/A	N/A	All	34	Phase 3	Korea, Republic of
2	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
3	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
4	EUCTR2007-004716-31-NL (EUCTR)	05/03/2008	06/11/2007	Effects 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	Effects 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: Genotropin	Dutch Growth Foundation	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Netherlands

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

NCT02204163
(ClinicalTrials.gov)

June 2014

25/7/2014

Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome

A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi Syndrome

Prader-Willi Syndrome

Drug: Eutropin;Drug: Genotropin

LG Life Sciences

NULL

Completed

N/A

All

Phase 3

Korea, Republic of

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

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

Phase 1

United States

EUCTR2007-004716-31-NL
(EUCTR)

05/03/2008

06/11/2007

Effects 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: Genotropin

Dutch Growth Foundation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Netherlands