Pregabalin Versus Placebo as an Add on for Complex Regional Pain Syndrome (CPRS) of the Upper Limb Managed by Stellate Ganglion Block (The PREGA Study) - Full Text View

Sponsor:	Hamilton Health Sciences Corporation
Collaborator:	Pfizer
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00891397

Purpose

The purpose of this study is to assess the efficacy of pregabalin in patients with complex regional pain syndrome Type I and to determine whether it provides clinically significant pain relief and whether it improves functioning of the upper limb.

Condition	Intervention
Complex Regional Pain Syndromes	Drug: Pregabalin Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block

Resource links provided by NLM:

MedlinePlus related topics: Complex Regional Pain Syndrome

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	November 2007
Study Completion Date:	October 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Pregabalin group is made up of 20 patients. Patients will receive 150mg/day in two divided does. The patients will be assessed weekly and the dose can be increased to 300mg/day, if the patient does not report any decrease in pain. The following week the dose may be increased to 600mg/day if once again the patient reports no decrease in pain. This is also the maximum permissible does that will be given to the patient. If patient reports any side effects then the dose can be decreased once. The time period of 2 to 5 weeks will be the dose adjustment period. After which the drug maintenance period extends from week 5 to 12. All doses will be given in two divided doses/day.	Drug: Pregabalin Dose of 150mg/day divided in two doses. Increased to 300mg/day then to 600mg/day, always divided in two doses for the day. Other Name: Lyrica
Placebo Comparator: 2 Ten patients will be be in the placebo group.	Other: Placebo Sugar pill

Arms

Assigned Interventions

Experimental: 1

Pregabalin group is made up of 20 patients. Patients will receive 150mg/day in two divided does. The patients will be assessed weekly and the dose can be increased to 300mg/day, if the patient does not report any decrease in pain. The following week the dose may be increased to 600mg/day if once again the patient reports no decrease in pain. This is also the maximum permissible does that will be given to the patient. If patient reports any side effects then the dose can be decreased once. The time period of 2 to 5 weeks will be the dose adjustment period. After which the drug maintenance period extends from week 5 to 12. All doses will be given in two divided doses/day.

Drug: Pregabalin

Dose of 150mg/day divided in two doses. Increased to 300mg/day then to 600mg/day, always divided in two doses for the day.

Other Name: Lyrica

Placebo Comparator: 2

Ten patients will be be in the placebo group.

Other: Placebo

Sugar pill

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients diagnosed with CRPS Type I as per the IASP (International Association for the Study of Pain) criteria which states presence of an initiating noxious event, or cause for immobilization
Evidence at some point of swelling, color change, hot/cold/sweaty sensation and no other condition which can account for the pain and dysfunction of the upper limb
Men or women between ages 18-65 year old
Women should not be pregnant or breast feeding
No change in treatment for 4 weeks prior to recruitment
Pain scores of 4/10 on a verbal analogue scale

Exclusion Criteria:

Patients with a neurologic disorder unrelated to CRPS
Patients who are already on pregabalin
Patients with renal impairment whose creatinine clearance is less than 60 ml/min
Patients with congestive heart failure who are also diabetic and taking thiazolidinedione medication like rivoglitazone
Unstable psychiatric history
Patients with another problem with equal or worse pain
Unstable medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891397

Locations

Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Pfizer

Investigators

Principal Investigator:

Norman Buckley, MD

Hamilton Health Sciences Corporation

More Information

Publications:

Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain. 2005 Jun;115(3):254-63. Epub 2005 Apr 18.

Responsible Party:	Dr. Norman Buckley, MD, McMaster University/Hamilton Health Sciences
ClinicalTrials.gov Identifier:	NCT00891397 History of Changes
Other Study ID Numbers:	07-181
Study First Received:	April 28, 2009
Last Updated:	March 4, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

CPRS
stellate ganglion block
pregabalin
pain
Type I

Additional relevant MeSH terms:

Synovial Cyst
Ganglion Cysts
Somatoform Disorders
Complex Regional Pain Syndromes
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases

Peripheral Nervous System Diseases
Neuromuscular Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 24, 2012