Pregabalin Peripheral Neuropathic Pain Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141219
First received: August 30, 2005
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathies
Neuralgia
Drug: pregabalin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ] [ Designated as safety issue: No ]
  • Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores) [ Time Frame: Endpoint- Week 8 or Early Discontination ] [ Designated as safety issue: No ]
  • Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score [ Time Frame: Weeks 1 to 8 ] [ Designated as safety issue: No ]
  • Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score [ Time Frame: Weeks 1 to 8 ] [ Designated as safety issue: No ]
  • Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS). [ Time Frame: Endpoint- Week 8 or Early Discontinuation ] [ Designated as safety issue: No ]
  • Mean Sleep Score as Computed by DSIS. [ Time Frame: Weeks 1 to 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Sleep Disturbance [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Snoring Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Awaken Short of Breath or Headache [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Sleep Quantity [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Sleep Adequacy [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Somnolence [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Overall Sleep Problems Index [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Euro Quality of Life (QOL) (EQ-5D) Utility Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale- Depression (HADS-D) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGIC) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score [ Time Frame: Weeks 1 to 8 ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pregabalin
150-600mg/day, BID
Placebo Comparator: 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  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: NCT00141219

Locations
Korea, Republic of
Pfizer Investigational Site
Sungnam-si, Gyeonggi-do, Korea, Republic of, 463-802
Pfizer Investigational Site
Suwonsi, Gyeonggi-do, Korea, Republic of, 443-721
Pfizer Investigational Site
Busan, Korea, Republic of, 602-739
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-715
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-720
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 130-702
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00141219     History of Changes
Other Study ID Numbers: A0081037
Study First Received: August 30, 2005
Results First Received: December 19, 2008
Last Updated: September 23, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014