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)
This study has been terminated.
(Unable to recruit patients)
Sponsor:
Hamilton Health Sciences Corporation
Collaborator:
Pfizer
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00891397
First received: April 28, 2009
Last updated: March 4, 2011
Last verified: June 2009
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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
|
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:
| 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 23, 2013