A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00599638
First received: January 4, 2008
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.


Condition Intervention Phase
Postherpetic Neuralgia
Drug: pregabalin
Drug: pregabalin/PF-00489791
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Two Week Double-Blind Placebo-Controlled Crossover Study To Compare The Efficacy And Safety Of A Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Patients With Post-Herpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint will be the 11-point Daily Pain Rating Scale. This will be collected daily by means of a telephone interactive voice recognition (IVR) system. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy endpoints will consist of the Patient Global Assessment of Change (PGIC), and the Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Safety endpoints will consist of adverse event reports, vital signs (blood pressure and heart rate) sitting and standing, 12-lead ECG, and laboratory safety tests. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: pregabalin
75mg bid titrating to 150mg bid on day 4
Experimental: 2 Drug: pregabalin/PF-00489791
Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
Placebo Comparator: 3 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of non-childbearing potential
  • Pain present for more than 3 months after healing of herpes zoster skin rash
  • VAS score of >=40mm at screening and baseline visits

Exclusion Criteria:

  • Patients with pain conditions which might impair the assessment of postherpetic neuralgia
  • Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
  • History or diagnosis of DSM IV major depressive disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599638

  Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00599638     History of Changes
Other Study ID Numbers: B0261002
Study First Received: January 4, 2008
Last Updated: October 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014