Pregabalin Peripheral Neuropathic Pain Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141219

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 III

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Endpoint Mean Pain Scores from DPRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of 30% Responders (With Respect to Pain Scores) at Endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Proportion of 50% Responders (With Respect to Pain Scores) at Endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	241
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pregabalin 150-600mg/day, BID
2: Placebo Comparator	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 <60 to >30mL/min is 300 mg/day

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141219

Locations

Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 130-702
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-720
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-715
Pfizer Investigational Site
Busan, Korea, Republic of, 602-739
Korea, Republic of, Gyeonggi-do
Pfizer Investigational Site
Sungnam-si, Gyeonggi-do, Korea, Republic of, 463-802
Pfizer Investigational Site
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-721

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081037
Study First Received:	August 30, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00141219
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Pregabalin
Neurologic Manifestations
Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009