Pregabalin Peripheral Neuropathic Pain Study

NCT00141219 | Completed Phase 3 Results

• 1 other identifier: A0081037
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 10

Brief Summary

To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

Conditions

Diabetic Neuropathies; Neuralgia

Outcome Measures

Primary Outcomes (1)

• Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)

  DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.

  Endpoint- Week 8 or Early Discontinuation

Secondary Outcomes (21)

• Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)

  Endpoint- Week 8 or Early Discontinuation

• Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)

  Endpoint- Week 8 or Early Discontination

• Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score

  Weeks 1 to 8

• Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score

  Weeks 1 to 8

• Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).

  Endpoint- Week 8 or Early Discontinuation

Other Outcomes (1)

• Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)

  Endpoint- Week 8 or Early Discontinuation

Study Arms (2)

1

EXPERIMENTAL

Drug: pregabalin

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pregabalin DRUG

150-600mg/day, BID

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
• Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

You may not qualify if:

• Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
• Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
• Creatinine clearance \< 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (10)

Pfizer Investigational Site

Sungnam-si, Gyeonggi-do, 463-802, South Korea

Location

Pfizer Investigational Site

Suwon, Gyeonggi-do, 443-721, South Korea

Location

Pfizer Investigational Site

Busan, 602-739, South Korea

Location

Pfizer Investigational Site

Daegu, 705-715, South Korea

Location

Pfizer Investigational Site

Gwangju, 501-757, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 130-702, South Korea

Location

Pfizer Investigational Site

Seoul, 135-720, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 9, 2021
• Results First Posted: March 13, 2009

Record last verified: 2009-09

Locations

KR (10)