Back to resultsA 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
Primary Purpose
Postherpetic Neuralgia, Shingles, Herpes Zoster
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KD7040 Topical Gel
Placebo gel
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
Eligibility 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.
Sites / Locations
- United Bioscience Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KD7040 topical gel
Placebo gel
Arm Description
Outcomes
Primary Outcome Measures
Worst daily pain
Secondary Outcome Measures
Average daily pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00576108
Brief Title
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kalypsys, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Shingles, Herpes Zoster, Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KD7040 topical gel
Arm Type
Experimental
Arm Title
Placebo gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KD7040 Topical Gel
Intervention Description
KD7040 topical gel
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Intervention Description
Placebo gel
Primary Outcome Measure Information:
Title
Worst daily pain
Time Frame
Once daily
Secondary Outcome Measure Information:
Title
Average daily pain
Time Frame
Once daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
United Bioscience Corporation
City
Kansas City
State/Province
Missouri
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
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