NCT01243307

A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Creabilis SA · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	CT327 (or placebo) followed by placebo (or CT327)	During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2010-11-18
• Last updated: 2011-06-08

Locations

1 site across 1 country: Denmark