Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00629681
Previous Study | Return to List | Next Study

A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic 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: NCT00629681
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 26, 2008
First Posted Date  ICMJE March 6, 2008
Last Update Posted Date April 26, 2011
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters [ Time Frame: Baseline to Week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00629681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
  • Mean sleep score from patient's daily sleep interference diary [ Time Frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28 ]
  • Change from baseline in mean sleep score from patient's daily sleep interference diary [ Time Frame: End of treatment ]
  • Mean anxiety score from patient's daily anxiety diary [ Time Frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28 ]
  • Adverse events [ Time Frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28 ]
  • Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score [ Time Frame: End of treatment ]
  • Median time to pain response profile [ Time Frame: Over the first week ]
  • CGIC and PGIC [ Time Frame: End of treatment ]
  • Change from baseline in EuroQOL (as measures by EQ-5D) [ Time Frame: End of treatment ]
  • Change from baseline in mean anxiety score from patient's daily anxiety diary [ Time Frame: End of treatment ]
  • Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score [ Time Frame: End of treatment ]
  • Course of mean pain score of patient's daily pain diary (NRS) [ Time Frame: Throughout the study ]
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 of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
Official Title  ICMJE Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
Brief Summary The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Neuropathy and Post Herpetic Neuralgia
Intervention  ICMJE Drug: Pregabalin
Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Pregabalin
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
Actual Enrollment  ICMJE
 (submitted: April 22, 2011)
217
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2008)
300
Actual Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Diagnosis of DPN or PHN
  • Score on the Numeric Rating Scale of at least 4/10

Exclusion Criteria:

  • Hospitalized patients
  • Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00629681
Other Study ID Numbers  ICMJE A0081031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial 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 April 2011

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