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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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 ]

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 ]
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00599638

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

Additional Information:
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

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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2017