Skip to main content
OpenTrials
Completed

NCT Number: NCT00576108

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

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

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KD7040 Topical Gel

Drug

KD7040 topical gel

Placebo Gel

Drug

Placebo gel

Primary outcomes

  1. Worst daily pain

    Time frame: Once daily

Secondary outcomes

  1. Average daily pain

    Time frame: Once daily

Sponsors and collaborators

Lead sponsor

Kalypsys, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2007
Registry last updated
Jul 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.