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NCT00266669
Phase III "in-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon
Phase 3 trial testing Topical organogel with nitroglycerin in Raynaud's Disease in 200 participants. Completed in 1 May 2006.
Quick facts
| Lead sponsor | MediQuest Therapeutics |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 December 2005 |
| Estimated completion | 1 May 2006 |
| Sites | 19 locations across United States, Canada |
Drugs / interventions tested
- Topical organogel with nitroglycerin — full drug profile →
Conditions studied
- Raynaud's Disease — all drugs for Raynaud's Disease →
Sponsor
MediQuest Therapeutics — full company profile →
Who can join
Adults 18 to 70, any sex, with Raynaud's 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.
- Improvements in Raynaud's Assessment Score comparing active to placebo
- Reduction of number of Raynaud's events
- Decrease in duration of Raynaud's events
- Decrease in symptoms associated with Raynaud's
- Assess safety: frequency and severity of adverse events associated with the study drug
Sponsor's own description
The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Evaluation of test characteristics for outcome measures used in Raynaud's phenomenon clinical trials.
Gladue H, Maranian P, Paulus HE, Khanna D. · · 2013 · cited 28× · PMID 22972592 · DOI 10.1002/acr.21858 -
Vasodilators for primary Raynaud's phenomenon.
Su KY, Sharma M, Kim HJ, Kaganov E, et al · · 2021 · cited 15× · PMID 33998674 · DOI 10.1002/14651858.cd006687.pub4
Verify or expand the search:
- PubMed search for NCT00266669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Raynaud's Disease
Currently open trials in the same condition.
- NCT07112183 — Open Label Treprostinil Raynaud's Study · Phase 4 · 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 NCT00266669 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MediQuest Therapeutics
- Last refreshed: 6 August 2007
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/NCT00266669.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing