A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
This study has been completed.
Sponsor:
Kalypsys, Inc.
Information provided by:
Kalypsys, Inc.
ClinicalTrials.gov Identifier:
NCT00576108
First received: December 14, 2007
Last updated: July 18, 2008
Last verified: July 2008
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Purpose
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
| Condition | Intervention | Phase |
|---|---|---|
|
Postherpetic Neuralgia Shingles Herpes Zoster Neuropathic Pain |
Drug: KD7040 Topical Gel Drug: Placebo gel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Kalypsys, Inc.:
Primary Outcome Measures:
- Worst daily pain [ Time Frame: Once daily ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average daily pain [ Time Frame: Once daily ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: KD7040 topical gel |
Drug: KD7040 Topical Gel
KD7040 topical gel
|
| Placebo Comparator: Placebo gel |
Drug: Placebo gel
Placebo gel
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Kalypsys, Inc. |
| ClinicalTrials.gov Identifier: | NCT00576108 History of Changes |
| Other Study ID Numbers: | KD7040-NP02 |
| Study First Received: | December 14, 2007 |
| Last Updated: | July 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Herpes Zoster Neuralgia Neuralgia, Postherpetic Herpesviridae Infections DNA Virus Infections Virus Diseases |
Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013