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

This study has been completed.
Sponsor:
Information provided by:
Kalypsys, Inc.
ClinicalTrials.gov Identifier:
NCT00576108
First received: December 14, 2007
Last updated: July 18, 2008
Last verified: July 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576108

Locations
United States, Missouri
United Bioscience Corporation
Kansas City, Missouri, United States
Sponsors and Collaborators
Kalypsys, Inc.
  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 July 28, 2014