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NCT00954057
A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease
Phase 2 trial testing LIPO-102 in Thyroid-Related Eye Disease in 11 participants. Completed in 1 June 2011.
1 June 2011
Quick facts
| Lead sponsor | Neothetics, Inc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 1 September 2009 |
| Primary completion | 1 June 2011 |
| Estimated completion | 1 June 2011 |
| Sites | 5 locations across Australia, New Zealand |
Drugs / interventions tested
- LIPO-102 — full drug profile →
- Placebo
Conditions studied
- Thyroid-Related Eye Disease — all drugs for Thyroid-Related Eye Disease →
Sponsor
Neothetics, Inc — full company profile →
Who can join
Adults 18 to 65, any sex, with Thyroid-Related Eye Disease. 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.
-
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Time frame: 8 weeks treatment and 1 week follow up
Sponsor's own description
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
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 NCT00954057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Neothetics, Inc trials
Trials by the same sponsor.
- NCT03005717 — Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat · Phase 2 · completed
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 NCT00954057 (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 Neothetics, Inc
- Last refreshed: 5 March 2015
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/NCT00954057.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing