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

Neuropathic Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576108
• Other study ID #: KD7040-NP02
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2007
• Last updated: July 18, 2008
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Kalypsys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain
• Postherpetic Neuralgia
• Shingles

Intervention

Drug:
• KD7040 Topical Gel
KD7040 topical gel
• Placebo gel
Placebo gel

Locations

Country	Name	City	State
United States	United Bioscience Corporation	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kalypsys, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst daily pain		Once daily	No
Secondary	Average daily pain		Once daily	No