A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
NCT ID: NCT00576108
Last Updated: 2008-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2007-11-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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KD7040 topical gel
KD7040 Topical Gel
KD7040 topical gel
Placebo gel
Placebo gel
Placebo gel
Interventions
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KD7040 Topical Gel
KD7040 topical gel
Placebo gel
Placebo gel
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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Kalypsys, Inc.
INDUSTRY
Responsible Party
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Kalypsys, Inc.
Locations
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United Bioscience Corporation
Kansas City, Missouri, United States
Countries
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Other Identifiers
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KD7040-NP02
Identifier Type: -
Identifier Source: org_study_id