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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403780
Recruitment Status : Unknown
Verified May 2015 by Jonas Malmstedt, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : November 27, 2006
Last Update Posted : May 8, 2015
Karolinska University Hospital
Information provided by (Responsible Party):
Jonas Malmstedt, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Arterial Occlusive Disease Pain Ischemia Drug: pregabalin Drug: placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study
Study Start Date : June 2006
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Active intervention with pregabalin
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.

Other Name: Capsule Lyrica 75mg. Manufacturer company: Pfizer
Placebo Comparator: B
placebo arm with capsule Lyrica Placebo
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.
Other Name: Lyrica Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. The amount, dose and duration of concomitant pain medication use during study compared to use before study. [ Time Frame: 2 weeks after randomization ]
  3. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403780

Contact: Eric Wahlberg, MD, PhD +46 8 517 70000 ext 2239
Contact: Jonas Malmstedt, MD +46 8 517 70000 ext 6895

Deptartment of Vascular Surgery, Sahlgrenska University Hospital Active, not recruiting
Gothenburg, Sweden
Department of Vascular Surgery, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-171 76
Contact: Jonas Malmstedt, MD    +46 8 517 70000 ext 6895   
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         
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Principal Investigator: Eric Wahlberg, MD. PhD Karolinska Institutet

Responsible Party: Jonas Malmstedt, PhD, Karolinska Institutet Identifier: NCT00403780     History of Changes
Other Study ID Numbers: PREPARED_00
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Jonas Malmstedt, Karolinska Institutet:
Critical limb ischemia
Pain control
Rest pain in lower limb ischemia
randomized controlled study
Ischemia, therapy
Lower extremity, blood supply
Pain, prevention & control
Pain, therapy

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs