Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00219544

Purpose

This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).

Condition	Intervention	Phase
Neuropathic Pain	Drug: Pregabalin (Lyrica) Drug: Placebo	Phase III

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain

Further study details as provided by Pfizer:

Primary Outcome Measures:

Evaluate the efficacy of pregabalin in relieving neuropathic pain in patients with peripheral neuropathic pain. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the safety and tolerability of pregabalin. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Evaluate improvement in subject-reported sleep interference due to pain. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Evaluate the impact of treatment on the subject-reported levels of mood disturbance and anxiety. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	158
Study Start Date:	November 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Pregabalin (Lyrica) pregabalin 150mg/day (150mg BID)
2: Experimental	Drug: Pregabalin (Lyrica) pregabalin 300 mg/day (75 mg BID)
3: Experimental	Drug: Pregabalin (Lyrica) pregabalin 600/day (300mg BID)
4: 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:

Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

Exclusion Criteria:

Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219544

Locations

Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4N1
Pfizer Investigational Site
Red Deer, Alberta, Canada, T4N 6V7
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5N 3Y6
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5J 3N4
Pfizer Investigational Site
Calgary, Alberta, Canada, T3B 0M3
Pfizer Investigational Site
Calgary, Alberta, Canada, T2S 3C3
Canada, British Columbia
Pfizer Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6Z 2E8
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R2V 3P4
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3J 3T1
Canada, Ontario
Pfizer Investigational Site
Port Hope, Ontario, Canada, L1A 3Y9
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 2V7
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Pfizer Investigational Site
London, Ontario, Canada, N6A 4V2
Canada, Prince Edward Island
Pfizer Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 2M5
Canada, Quebec
Pfizer Investigational Site
Ste-Foy, Quebec, Canada, G1V 4P9
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Pfizer Investigational Site
Laval, Quebec, Canada, H7M 3L9
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Pfizer Investigational Site
Levis, Quebec, Canada, G6V 3Z1
Pfizer Investigational Site
Montreal, Quebec, Canada, H3A 2B4
Pfizer Investigational Site
Sherbrook, Quebec, Canada, J1H 4J6
Pfizer Investigational Site
Laval, Quebec, Canada, H7T 2P5
Pfizer Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Pfizer Investigational Site
Granby, Quebec, Canada, J2G 8Z9
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081084
Study First Received:	September 13, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00219544 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Pregabalin
Pain
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

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

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009