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

NCT00576108 | Completed Phase 2

• 1 other identifier: KD7040-NP02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postherpetic Neuralgia; Shingles; Herpes Zoster; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Worst daily pain

  Once daily

Secondary Outcomes (1)

• Average daily pain

  Once daily

Study Arms (2)

KD7040 topical gel

EXPERIMENTAL

Drug: KD7040 Topical Gel

Placebo gel

PLACEBO COMPARATOR

Drug: Placebo gel

Interventions

KD7040 Topical Gel DRUG

KD7040 topical gel

KD7040 topical gel

Placebo gel DRUG

Placebo gel

Placebo gel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kalypsys, Inc.: lead

Study Sites (1)

United Bioscience Corporation

Kansas City, Missouri, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

US (1)