CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
somapacitan +1 moredrug
Likely dose
Somapacitan: once weekly subcutaneous injections; Norditropin: daily subcutaneous injectionsAI-extracted
Key inclusion· 4
  • ✓Male or female, 18–79 years old
  • ✓GHD diagnosed for at least 6 months prior to screening
  • ✓Prior hGH treatment for at least 6 consecutive months at screening
  • ✓If on other hormone replacement therapies, must be adequate and stable for at least 90 days prior to randomization
Key exclusion· 3
  • ✕Active malignant disease or history of malignancy, with exceptions for resected cervical in situ carcinoma and skin carcinomas with complete local excision
  • ✕Subjects with GHD from prior malignancy treatment must have ≥5 years recurrence-free survival documented
  • ✕For pituitary adenoma or benign intracranial tumor resection/debulking within 5 years: evidence of tumor growth within 12 months before randomization excludes; must have two post-surgery MRI or CT scans with no growth documented, most recent ≤9 months prior to randomization

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

Search/NCT03075644
NCT03075644Phase 3Completed
CompareCT.gov

A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Novo Nordisk A/S·interventional·Posted Mar 9, 2017·Updated Nov 23, 2020

In Brief

A Phase 3 clinical trial evaluating somapacitan and Norditropin for Growth Hormone Disorder and Adult Growth Hormone Deficiency. Completed, enrolled 62 participants across 12 sites.

Detailed Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Disorder, Adult Growth Hormone Deficiency
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartMar 3, 2017
Primary CompletionOct 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.3 years ago

Interventions

somapacitandrug

Once weekly subcutaneous injections (s.c., under the skin)

Norditropindrug

Daily subcutaneous injections (s.c., under the skin)