NCT05029297

Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

Study of Efficacy and Non-inferiority, With Two Capsaicin Topic Treatments, for the Moderate to Severe Pain in Diabetic Neuropathy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Arafarma Group, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial of "line extension" of drug ARAFARMADOL® 0.075% cream in a new formulation in topical solution applicable in roll-on and with the same therapeutic indications approved for the cream.

Detailed description

The sponsor created a new pharmaceutical formulation of CAPSAICIN topical solution applicable in roll-on. This new formulation in roll-on represents a line extension of drug ARAFARMADOL 0.075 cream, which is currently marketed in Spain by the sponsor. The proposed investigational product as topical solution applicable in roll-on is expected to solve the compliance and safety issues of the cream with the same indications for use. Eligible patients will be randomized into two groups: CAPSAICIN topical solution applicable in roll-on and CAPSAICIN cream (ARAFARMADOL® ) for 8 weeks. Then, they will have a 4 week washout period and will be crossed over to the other treatment group for 8 weeks. A follow-up period of 2 weeks will take place after the end of both treatments.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
DRUG	Capsaicin

Timeline

• Start date: 2010-11-04
• Primary completion: 2018-10-23
• Completion: 2018-10-23
• First posted: 2021-08-31
• Last updated: 2021-09-14