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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)

Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complex Regional Pain Syndromes

Intervention: Pregabalin (Drug); Placebo (Other)

Phase: N/A

Status: Terminated

Sponsored by: McMaster University

Official(s) and/or principal investigator(s):
Norman Buckley, MD, Principal Investigator, Affiliation: Hamilton Health Sciences Corporation

Summary

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.

Clinical Details

Official title: Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.

Secondary outcome: Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Related 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.

Starting date: November 2007
Last updated: April 7, 2015

Page last updated: August 23, 2015

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