At a glance
ClinicalIndex Comparison RecordN/ACompleted· 65,205 enrolled
Drug / intervention
Somatrem +1 morebiological
Likely dose
Not stated in record
Key inclusion· 3
- ✓Open epiphyses
- ✓Children treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for growth failure
- ✓Willing to keep follow-up appointments throughout study participation
Key exclusion· 3
- ✕Treatment with non-Genentech GH preparation
- ✕Closed epiphyses
- ✕Active neoplasia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Genentech National Cooperative Growth Study (NCGS) Post-Marketing Surveillance Program For Nutropin AQ® (Somatropin [rDNA Origin] Injection), Nutropin® (Somatropin [rDNA Origin] for Injection), and Protropin® (Somatrem for Injection)
In Brief
An observational study evaluating Somatrem and Somatropin for Growth Disorders. Completed, enrolled 65,205 participants.
Detailed Summary
The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Disorders
Countries--
Collaborators--
Timeline
N/ACompletedFinished
1985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 1985
First PostedNov 2004
Primary CompletionJun 2010
TodayJul 2026
First PostedNov 25, 2004
Enrollment StartOct 1, 1985
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 24.7 yearsPosted 21.6 years ago
Interventions
Somatrembiological
Somatropinbiological