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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576108
First Posted: December 18, 2007
Last Update Posted: July 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kalypsys, Inc.
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Average daily pain [ Time Frame: Once daily ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576108


Locations
United States, Missouri
United Bioscience Corporation
Kansas City, Missouri, United States
Sponsors and Collaborators
Kalypsys, Inc.
  More Information

Responsible Party: Kalypsys, Inc.
ClinicalTrials.gov Identifier: NCT00576108     History of Changes
Other Study ID Numbers: KD7040-NP02
First Submitted: December 14, 2007
First Posted: December 18, 2007
Last Update Posted: July 22, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Neuralgia
Herpes Zoster
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases