Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
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.
Critical Limb Ischemia
Arterial Occlusive Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study|
- Reduction in Rating Scale (RS) pain compared to baseline. RS Pain will be assessed at 7, 14 days for all participants and after 28 and 56 days for patients continuing the extended phase of study. [ Time Frame: 1, 2, 4 and 8 weeks after randomization ] [ Designated as safety issue: No ]
- Improvement in the Short Form 36 (SF-36) parameter "bodily pain". [ Time Frame: This parameter will be evaluated at baseline, after seven and 14 days of treatment. Patients continuing in the study will be scored also at 28 and 56 days. ] [ Designated as safety issue: No ]
- The amount, dose and duration of concomitant pain medication use during study compared to use before study. [ Time Frame: 2 weeks after randomization ] [ Designated as safety issue: No ]
- Safety outcomes and adverse events will be examined and recorded throughout the study. Patient reported dizziness will be recorded separately in the CRF, as well as blood pressure at visits. [ Time Frame: up to 8 weeks, as long as patients is in the study. ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: A
Active intervention with 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.
Other Name: Capsule Lyrica 75mg. Manufacturer company: Pfizer
Placebo Comparator: B
placebo arm with capsule Lyrica 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.
Other Name: Lyrica Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403780
|Contact: Eric Wahlberg, MD, PhD||+46 8 517 70000 ext firstname.lastname@example.org|
|Contact: Jonas Malmstedt, MD||+46 8 517 70000 ext email@example.com|
|Deptartment of Vascular Surgery, Sahlgrenska University Hospital||Active, not recruiting|
|Department of Vascular Surgery, Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, SE-171 76|
|Contact: Jonas Malmstedt, MD +46 8 517 70000 ext 6895 firstname.lastname@example.org|
|Principal Investigator: Jonas Malmstedt, MD|
|Sub-Investigator: Ulrika Palmer-Kazen, MD, PhD|
|Deptartment of Surgery, South Hospital||Not yet recruiting|
|Contact: Peter Konrad, MD, PhD|
|Principal Investigator: Peter Konrad, MD, PhD|
|Principal Investigator:||Eric Wahlberg, MD. PhD||Karolinska Institutet|