Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00599638
Previous Study | Return to List | Next Study

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

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.
ClinicalTrials.gov Identifier: NCT00599638
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : October 12, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 4, 2008
First Posted Date  ICMJE January 24, 2008
Last Update Posted Date October 12, 2009
Study Start Date  ICMJE March 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00599638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia
Intervention  ICMJE
  • Drug: pregabalin
    75mg bid titrating to 150mg bid on day 4
  • 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
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: pregabalin
  • Experimental: 2
    Intervention: Drug: pregabalin/PF-00489791
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 11, 2008)
130
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599638
Other Study ID Numbers  ICMJE B0261002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP