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NCT00253331
Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
Phase 2/Phase 3 trial testing topical organogel with nitroglycerin in Raynaud Disease in 36 participants. Completed in 1 September 2005.
Quick facts
| Lead sponsor | MediQuest Therapeutics |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 1 November 2004 |
| Estimated completion | 1 September 2005 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- topical organogel with nitroglycerin — full drug profile →
Conditions studied
- Raynaud Disease — all drugs for Raynaud Disease →
- Raynaud Disease Secondary to Scleroderma — all drugs for Raynaud Disease Secondary to Scleroderma →
- Raynaud Secondary to Other Autoimmune Disease — all drugs for Raynaud Secondary to Other Autoimmune Disease →
Sponsor
MediQuest Therapeutics — full company profile →
Who can join
Adults 18 to 80, any sex, with Raynaud Disease or Raynaud Disease Secondary to Scleroderma. 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.
- Differntial time for blood flow to return to baseline following cold exposure.
Sponsor's own description
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures. Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours. Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
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 NCT00253331
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Raynaud Disease
Currently open trials in the same condition.
- NCT06989216 — Multi-modal Quantitative Imaging of the Skin · 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 NCT00253331 (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 MediQuest Therapeutics
- Last refreshed: 29 May 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/NCT00253331.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing