NCT00234533 (OPTIMA) is a Phase 3 clinical trial of Somatropin (rDNA origin) in Turner Syndrome, sponsored by Ipsen.

Who is sponsoring NCT00234533?

NCT00234533 is sponsored by Ipsen.

What drugs are being tested in NCT00234533?

Interventions in NCT00234533: Somatropin (rDNA origin).

What condition does NCT00234533 study?

NCT00234533 studies Turner Syndrome, Renal Insufficiency, Chronic, Pituitary Diseases, Dwarfism.

Is NCT00234533 still recruiting?

NCT00234533 is currently completed. Last updated 21 November 2019.

Are results published for NCT00234533?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-21 · How we verify

NCT00234533: OPTIMA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method

Completed Phase 3 Results posted Last updated 21 November 2019

What this trial tests

Phase 3 trial testing Somatropin (rDNA origin) in Turner Syndrome in 251 participants. Completed in 1 July 2008.

Timeline

1 June 2004

Primary endpoint
1 July 2008

1 July 2008

Quick facts

Lead sponsor	Ipsen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	251
Start date	1 June 2004
Primary completion	1 July 2008
Estimated completion	1 July 2008
Sites	45 locations across Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy

Drugs / interventions tested

Somatropin (rDNA origin) — full drug profile →

Conditions studied

Turner Syndrome — all drugs for Turner Syndrome →
Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →
Pituitary Diseases — all drugs for Pituitary Diseases →
Dwarfism — all drugs for Dwarfism →

Sponsor

Ipsen — full company profile →

Who can join

Under 18, any sex, with Turner Syndrome or Renal Insufficiency, Chronic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Time frame: At Weeks 21, 22 and 23
Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children. Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The s

Sponsor's own description

The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

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:

Other recruiting trials for Turner Syndrome

Currently open trials in the same condition.

NCT06834594 — Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome · Phase 4 · recruiting
NCT06507007 — Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome · recruiting
NCT06794190 — Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants · recruiting
NCT06780514 — Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome. · NA · recruiting
NCT05723835 — A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 · Phase 3 · active not recruiting

Other Ipsen trials

Trials by the same sponsor.

NCT07387549 — A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis · Phase 3 · not yet recruiting
NCT07497724 — Retrospective Observational Study of Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-P · not yet recruiting
NCT07427797 — A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between · Phase 3 · recruiting
NCT07435428 — A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Line · Phase 3 · recruiting
NCT07441707 — A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours · Phase 1 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00234533 (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 Ipsen
Last refreshed: 21 November 2019

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/NCT00234533.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing