A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain

Condition	Intervention	Phase
Neuralgia	Drug: Pregabalin (Lyrica)	Phase III

Drug Information available for:

Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open Label, Non-Comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in weekly mean pain scores [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Adverse events and laboratory value changes [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: Yes ]
Change from baseline in weekly mean sleep interference score [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in Patient Global Impression of Change (PGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in Clinical Global Impression of Change (CGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	111
Study Start Date:	November 2004
Study Completion Date:	March 2005

Arms	Assigned Interventions
1: Experimental	Drug: Pregabalin (Lyrica) Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.

Eligibility

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

Criteria

Inclusion criteria:

Peripheral neuropathic pain
Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline

Exclusion criteria:

(none)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631943

Locations


India, Karnataka
	Pfizer Investigational Site
	Bangalore, Karnataka, India, 560054

India, Karnataka / India
	Pfizer Investigational Site
	Bangalore, Karnataka / India, India, 560 034

India, Maharashtra
	Pfizer Investigational Site
	Mumbai, Maharashtra, India, 400 012

India, MUMBAI
	Pfizer Investigational Site
	MAHARASHTRA, MUMBAI, India, 400 007

India, Tamil Nadu
	Pfizer Investigational Site
	Chennai, Tamil Nadu, India, 600 004

India, Tamil, Nadu
	Pfizer Investigational Site
	Chennai, Tamil, Nadu, India, 600 013

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

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0081068
First Received:	March 3, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00631943
Health Authority:	India: Drugs Controller General of India

Study placed in the following topic categories:

Signs and Symptoms

Neuromuscular Diseases

Neuralgia

Peripheral Nervous System Diseases

Pregabalin

Neurologic Manifestations

Pain

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 October 31, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00631943