A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

• ClinicalTrials.gov Identifier: NCT00629681
• Recruitment Status: Completed
• First Posted: March 6, 2008
• Last Update Posted: January 25, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: February 26, 2008
• First Posted Date: March 6, 2008
• Last Update Posted Date: January 25, 2021
• Study Start Date: November 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Painful Diabetic Neuropathy and Post Herpetic Neuralgia

Intervention

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

Experimental: 1

Intervention: Drug: Pregabalin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2011): 217
• Original Estimated Enrollment (submitted: February 26, 2008): 300
• Actual Study Completion Date: February 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00629681
• Other Study ID Numbers: A0081031
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2011