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NCT01243307
A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers
Phase 1 trial testing CT327 (or placebo) followed by placebo (or CT327) in Neuropathic Pain in 24 participants. Completed in 1 May 2011.
1 April 2011
Quick facts
| Lead sponsor | Creabilis SA |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 1 January 2011 |
| Primary completion | 1 April 2011 |
| Estimated completion | 1 May 2011 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- CT327 (or placebo) followed by placebo (or CT327) — full drug profile →
Conditions studied
- Neuropathic Pain — all drugs for Neuropathic Pain →
Sponsor
Creabilis SA — full company profile →
Who can join
Adults 18 to 64, male only, with Neuropathic Pain. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
An alteration in the peripheral sensitisation after treatment with CT327
Time frame: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days
Sponsor's own description
The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain. The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.
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 NCT01243307
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01243307 (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 Creabilis SA
- Last refreshed: 6 June 2011
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/NCT01243307.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing