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NCT02688270
A Double-blinded Crossover Study of Topical Formulation of Nitroglycerine, Vascana®, Versus Matching Vehicle in the Subjective and Physiologic Responses to Controlled Cold Challenge in Subjects With Raynaud's Phenomenon (RP) Secondary to Connective Tissue Disease
Phase 2 trial testing Vascana (0.9% nitroglycerin cream) in Raynaud's Phenomenon Secondary to Connective Tissue Disease in 65 participants. Completed in 1 December 2016.
1 December 2016
Quick facts
| Lead sponsor | Covis Pharma S.à.r.l. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 1 June 2016 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vascana (0.9% nitroglycerin cream) — full drug profile →
- Vehicle Cream (placebo)
Conditions studied
- Raynaud's Phenomenon Secondary to Connective Tissue Disease — all drugs for Raynaud's Phenomenon Secondary to Connective Tissue Disease →
Sponsor
Covis Pharma S.à.r.l. — full company profile →
Who can join
Adults 18 to 75, any sex, with Raynaud's Phenomenon Secondary to Connective Tissue 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.
-
Raynaud's Symptom Severity (Change From Baseline)
Time frame: 6 weeks
Change from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom. -
Raynaud's Symptom Severity (Percentage of Responders)
Time frame: 6 weeks
Sponsor's own description
The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands.
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 NCT02688270
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Covis Pharma S.à.r.l. trials
Trials by the same sponsor.
- NCT04377711 — A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients · Phase 3 · 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 NCT02688270 (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 Covis Pharma S.à.r.l.
- Last refreshed: 11 October 2022
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/NCT02688270.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing