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

July 18, 2008 updated by: Kalypsys, Inc.
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States
        • United Bioscience Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo gel
Drug: Placebo gel
Placebo gel
Experimental: KD7040 topical gel
Drug: KD7040 Topical Gel
KD7040 topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Worst daily pain
Time Frame: Once daily
Once daily

Secondary Outcome Measures

Outcome Measure
Time Frame
Average daily pain
Time Frame: Once daily
Once daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kalypsys, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

July 22, 2008

Last Update Submitted That Met QC Criteria

July 18, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD7040-NP02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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