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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Limb Ischemia Arterial Occlusive Disease Pain Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Active intervention with pregabalin

Group Type ACTIVE_COMPARATOR

pregabalin

Intervention Type DRUG

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.

B

placebo arm with capsule Lyrica Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Capsule Lyrica 75mg. Manufacturer company: Pfizer Lyrica Placebo

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No