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NCT02666846
A Randomised, Double Blind, Cross Over Clinical Study in Healthy Human Volunteers to Assess the Efficacy and Safety of Three Different Topical Analgesics (DCF100, TIB200 And SPR300) Versus in a Model of UV-Induced Inflammatory Pain
Phase 1 trial testing Ibuprofen in Pain in 60 participants. Completed in 1 May 2015.
1 May 2015
Quick facts
| Lead sponsor | Futura Medical Developments Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 March 2015 |
| Primary completion | 1 May 2015 |
| Estimated completion | 1 May 2015 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Ibuprofen (ibuprofen) — full drug profile →
- Diclofenac (DICLOFENAC) — full drug profile →
- Methyl-salicylate / Menthol — full drug profile →
- Placebo
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Futura Medical Developments Ltd. — full company profile →
Who can join
Adults 18 to 65, male only, with Pain. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Heat Pain Tolerance Test (HPTT) Measured the Point at Which the Heat Became Painful - Degrees Centigrade -
Time frame: 15 minutes before to 6 hours post administration
To assess the pharmacodynamic effect by Heat Pain Tolerance Test (HPTT) which measured the point at which the heat became painful (degrees centigrade) of three topical analgesics, DCF100, TIB200, and SPR300 versus topical placebo and active topical reference products in a model of UV-induced inflammatory pain. -
Intensity of the UVB-induced Erythema (Determined by Assessment of Skin Blood Flow by Laser Doppler Imaging [Flux Units])
Time frame: 15 minutes before to 6 hours post administration
Intensity of the Ultra Violet B radiation (UVB)-induced erythema (determined by assessment of skin blood flow by laser Doppler imaging \[flux units\], up to 8 subjects per cohort) - Change from baseline
Sponsor's own description
This is a randomised, double blind, cross over clinical study in healthy human volunteers (including pharmacokinetic \[PK\] sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain.
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 NCT02666846
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Futura Medical Developments Ltd. trials
Trials by the same sponsor.
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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 NCT02666846 (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 Futura Medical Developments Ltd.
- Last refreshed: 11 January 2021
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/NCT02666846.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing