NCT00403780

Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia

Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Critical Limb Ischemia
• Arterial Occlusive Disease
• Pain
• Ischemia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2013-05-01
• Completion: 2015-07-01
• First posted: 2006-11-27
• Last updated: 2018-06-15

Locations

3 sites across 1 country: Sweden