Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia - Full Text View

Sponsors and Collaborators:	Karolinska Institutet Karolinska University Hospital
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00403780

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 IV

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study

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
A: Active Comparator 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.
B: Placebo Comparator 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.

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

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
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
Deptartment of Vascular Surgery, Sahlgrenska University Hospital	Recruiting
Gothenburg, Sweden
Contact: Urban Vingren, MD, PhD
Principal Investigator: Urban Vingren, MD, PhD

Sponsors and Collaborators

Karolinska Institutet

Karolinska University Hospital

Investigators

Principal Investigator:

Eric Wahlberg, MD. PhD

Karolinska Institute, Stockholm, Sweden

More Information

Publications:

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.

Hultgren R, Olofsson P, Wahlberg E. Sex-related differences in outcome after vascular interventions for lower limb ischemia. J Vasc Surg. 2002 Mar;35(3):510-6.

Responsible Party:	Karolinska Institute ( Eric Wahlberg, MD PhD )
Study ID Numbers:	PREPARED_00
Study First Received:	November 24, 2006
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00403780 History of Changes
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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vascular Diseases
Pregabalin
Pain

Peripheral Nervous System Agents
Analgesics
Ischemia
Anticonvulsants

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Physiological Effects of Drugs
Vascular Diseases
Pregabalin
Ischemia
Pharmacologic Actions
Pathologic Processes

Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009