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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00403780
First received: November 24, 2006
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Critical Limb Ischemia
Arterial Occlusive Disease
Pain
Ischemia
Drug: pregabalin
Drug: placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403780

Contacts
Contact: Eric Wahlberg, MD, PhD +46 8 517 70000 ext 2239 eric.wahlberg@ki.se
Contact: Jonas Malmstedt, MD +46 8 517 70000 ext 6895 jonas.malmstedt@karolinska.se

Locations
Sweden
Deptartment of Vascular Surgery, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Urban Vingren, MD, PhD         
Principal Investigator: Urban Vingren, MD, PhD         
Department of Vascular Surgery, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-171 76
Contact: Jonas Malmstedt, MD    +46 8 517 70000 ext 6895    jonas.malmstedt@karolinska.se   
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
Investigators
Principal Investigator: Eric Wahlberg, MD. PhD Karolinska Institutet
  More Information

Publications:
Responsible Party: Eric Wahlberg, MD PhD, Karolinska Institute
ClinicalTrials.gov Identifier: NCT00403780     History of Changes
Other Study ID Numbers: PREPARED_00
Study First Received: November 24, 2006
Last Updated: January 28, 2009
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014