Trials / Completed
CompletedNCT02229851
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 23 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | somapacitan | Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration. |
| DRUG | somatropin | Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration. |
| DRUG | placebo | Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. |
Timeline
- Start date
- 2014-10-31
- Primary completion
- 2017-04-21
- Completion
- 2018-05-07
- First posted
- 2014-09-03
- Last updated
- 2020-11-23
- Results posted
- 2020-07-07
Locations
117 sites across 19 countries: United States, Australia, Brazil, Germany, India, Israel, Japan, Latvia, Lithuania, Malaysia, Norway, Poland, Romania, Russia, South Africa, Sweden, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02229851. Inclusion in this directory is not an endorsement.