CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 92 enrolled
Drug / intervention
somapacitan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02382939
NCT02382939Phase 3Completed
CompareCT.gov

A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Novo Nordisk A/S·interventional·Posted Mar 9, 2015·Updated Jul 9, 2020

In Brief

A Phase 3 clinical trial evaluating somapacitan and somatropin for Adult Growth Hormone Deficiency and Growth Hormone Disorder. Completed, enrolled 92 participants across 28 sites in 6 countries.

Detailed Summary

This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Growth Hormone Deficiency, Growth Hormone Disorder
CountriesDenmark, France, Germany, Japan, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 9, 2015
Enrollment StartFeb 12, 2015
Primary CompletionJan 4, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.3 years ago

Interventions

somapacitandrug

Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.

somatropindrug

Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.