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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00576108
Other study ID # KD7040-NP02
Secondary ID
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


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
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