A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)

Phase 2

Completed

• Conditions: Postherpetic Neuralgia; Shingles; Herpes Zoster; Neuropathic Pain
• Interventions: Drug: KD7040 Topical Gel; Drug: Placebo gel

• Registration Number: NCT00576108
• Lead Sponsor: Kalypsys, Inc.

Brief Summary

This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2008-07-18
• Last Update Posted: 2008-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Male or female subjects ages 18-85 years
• Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash
• Subject with intact skin in the targeted treatment area
• Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.
• Subject must be willing and able to complete screening and study procedures as described int he protocol.
• Subject must voluntarily provide written Informed Consent prior to participation.

Exclusion Criteria

• Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040.
• Subjects pregnant, nursing or planning to become pregnant.
• Subjects who are immunocompromised or have clinically significant hematological abnormalities.
• Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.
• Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.
• Subjects having other sever pain which may confound assessment of PHN.
• Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
KD7040 topical gel	KD7040 Topical Gel	-
Placebo gel	Placebo gel	-

Primary Outcome Measures

Name	Time	Method
Worst daily pain	Once daily

Secondary Outcome Measures

Name	Time	Method
Average daily pain	Once daily

Trial Locations

Locations (1)

United Bioscience Corporation; 🇺🇸 Kansas City, Missouri, United States