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NCT01502124
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
Phase 3 trial testing somatropin in Growth Hormone Disorder in 78 participants. Completed in 5 March 2003.
5 March 2003
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 8 May 2001 |
| Primary completion | 5 March 2003 |
| Estimated completion | 5 March 2003 |
| Sites | 21 locations across United States |
Drugs / interventions tested
- somatropin (Somatropin) — full drug profile →
- somatropin (Somatropin) — full drug profile →
Conditions studied
- Growth Hormone Disorder — all drugs for Growth Hormone Disorder →
- Growth Hormone Deficiency in Children — all drugs for Growth Hormone Deficiency in Children →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
Adults 3 to 17, any sex, with Growth Hormone Disorder or Growth Hormone Deficiency in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01502124
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of somatropin
Trials testing the same drug.
- NCT02726542 — Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents · EARLY_PHASE1 · completed
- NCT02382939 — A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Prev · Phase 3 · completed
- NCT02229851 — Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropi · Phase 3 · completed
- NCT02092077 — A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children · Phase 2 · terminated
- NCT01973244 — A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth · Phase 1 · completed
Other Novo Nordisk A/S trials
Trials by the same sponsor.
- NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
- NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01502124 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 28 February 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01502124.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing