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Sponsors and Collaborators: |
Karolinska Institutet Karolinska University Hospital |
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Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00403780 |
The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to the regular pain regimens for these patients.
Condition | Intervention | Phase |
---|---|---|
Critical Limb Ischemia Arterial Occlusive Disease Pain Ischemia |
Drug: pregabalin Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Active intervention with pregabalin
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Drug: pregabalin
Capsule pregabalin 75 mg once or twice daily up to a total dose of 600mg daily (300mg twice daily) for a total of minimum 14 days and maximum 8 weeks. Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily.
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B: Placebo Comparator
placebo arm with capsule Lyrica Placebo
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Drug: placebo
Capsule placebo once or twice daily up to a total dose of 8 capsules(4 capsules twice daily) for a total of minimum 14 days and maximum 8 weeks. Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily.
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Critical limb ischemia (CLI) is the end stage of peripheral arterial disease in the legs and is a consequence of deteriorating blood flow supply to the lower limbs. The clinical definition of CLI includes peripheral arterial disease and recurrent rest pain for at least two weeks with or without ulcers or gangrene.
In patients not amenable to revascularization - around 35% - amputation or palliative conservative care remains the options. Pain control is a vital part of any treatment of these patients. Besides being the principal conservative treatment, also patients undergoing revascularization experience severe pain both during work up and after surgery.
Experimental data indicate that pain in CLI is multimodal and to a large extent neuropathic. Still, current therapy is mostly based on opioid treatment, which clinically often affects pain moderately. The doses required to influence pain are also associated to severe side effects. Accordingly, there is a great need to improve pain control in the rather common disease CLI.
comparisons: pregabalin up to 600mg daily in addition to regular pain regimens compared to placebo and regular pain regimens.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric Wahlberg, MD, PhD | +46 8 517 70000 ext 2239 | eric.wahlberg@ki.se |
Contact: Jonas Malmstedt, MD | +46 8 517 70000 ext 6895 | jonas.malmstedt@karolinska.se |
Sweden | |
Department of Vascular Surgery, Karolinska University Hospital | Recruiting |
Stockholm, Sweden, SE-171 76 | |
Contact: Jonas Malmstedt, MD +46 8 517 70000 ext 6895 jonas.malmstedt@karolinska.se | |
Principal Investigator: Jonas Malmstedt, MD | |
Sub-Investigator: Ulrika Palmer-Kazen, MD, PhD | |
Deptartment of Surgery, South Hospital | Not yet recruiting |
Stockholm, Sweden | |
Contact: Peter Konrad, MD, PhD | |
Principal Investigator: Peter Konrad, MD, PhD | |
Deptartment of Vascular Surgery, Sahlgrenska University Hospital | Recruiting |
Gothenburg, Sweden | |
Contact: Urban Vingren, MD, PhD | |
Principal Investigator: Urban Vingren, MD, PhD |
Principal Investigator: | Eric Wahlberg, MD. PhD | Karolinska Institute, Stockholm, Sweden |
Responsible Party: | Karolinska Institute ( Eric Wahlberg, MD PhD ) |
Study ID Numbers: | PREPARED_00 |
Study First Received: | November 24, 2006 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00403780 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Critical limb ischemia Pain control Rest pain in lower limb ischemia pregabalin randomized controlled study |
Ischemia, therapy Lower extremity, blood supply Pain, prevention & control Pain, therapy |
Arterial Occlusive Diseases Vascular Diseases Pregabalin Pain |
Peripheral Nervous System Agents Analgesics Ischemia Anticonvulsants |
Arterial Occlusive Diseases Physiological Effects of Drugs Vascular Diseases Pregabalin Ischemia Pharmacologic Actions Pathologic Processes |
Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |