Critical Limb Ischemia | Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
Critical Limb Ischemia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Rest pain, gangrene or ulcers located below the patella for a duration of at least two weeks (either one of these criteria are sufficient). - One measurement of: Ankle blood pressure(ABP) <70 mm Hg, an toe blood pressure(TBP) <50, or a TcPO2<45 mm Hg, or an ankle/brachial pressure index <0.7 (either one of these criteria are sufficient). - Informed consent obtained Exclusion Criteria: - Age < 55 years - Women of childbearing potential - Patients already medicating with Pregabalin or Gabapentin - Creatinine clearance <30ml/min - Amputation necessary within two weeks - Revascularization necessary within two weeks (open vascular surgery or endovascular) - A medical history of clear dizziness - NYHA class IV heart failure - Known hypotension, or having a systolic arm blood pressure <120 mm Hg (two consecutive measurements with the patient lying supine) - Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices - Mental condition making the subject unable to understand the concepts and risk of the study - Known allergies against pregabalin
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Critical Limb Ischemia
Arterial Occlusive Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:pregabalinCapsule 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:placeboCapsule 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AActive intervention with pregabalin
Bplacebo arm with capsule Lyrica Placebo
Start Date: June 2006
Completed Date: July 2015
Phase: Phase 4
Primary Outcome: 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.
Secondary Outcome: Improvement in the Short Form 36 (SF-36) parameter "bodily pain".
Study sponsors, principal investigator, and references
Principal Investigator: Eric Wahlberg, MD. PhD
Lead Sponsor: Karolinska Institutet
Collaborator: Karolinska University Hospital
Caraceni A, Zecca E, Bonezzi C, Arcuri E, Yaya Tur R, Maltoni M, Visentin M, Gorni G, Martini C, Tirelli W, Barbieri M, De Conno F. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol. 2004 Jul 15;22(14):2909-17.