Status:
TERMINATED
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)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Pfizer
Hamilton Health Sciences Corporation
Conditions:
Complex Regional Pain Syndromes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 whe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00891397
Start Date
November 1 2007
End Date
October 1 2010
Last Update
April 8 2015
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2