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

Primary Purpose

Critical Limb Ischemia, Arterial Occlusive Disease, Pain

Status

Terminated

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

pregabalin

placebo

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Deptartment of Vascular Surgery, Sahlgrenska University Hospital
Department of Vascular Surgery, Karolinska University Hospital
Deptartment of Surgery, South Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Active intervention with pregabalin

placebo arm with capsule Lyrica Placebo

Outcomes

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.

Secondary Outcome Measures

Improvement in the Short Form 36 (SF-36) parameter "bodily pain".

The amount, dose and duration of concomitant pain medication use during study compared to use before study.

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.

Full Information

NCT ID

NCT00403780

First Posted

November 24, 2006

Last Updated

June 13, 2018

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00403780

Brief Title

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

Official Title

Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

low inclusion rate

Study Start Date

June 2006 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Limb Ischemia, Arterial Occlusive Disease, Pain, Ischemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Active intervention with pregabalin

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo arm with capsule Lyrica Placebo

Intervention Type

Drug

Intervention Name(s)

pregabalin

Other Intervention Name(s)

Capsule Lyrica 75mg. Manufacturer company: Pfizer

Intervention Description

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

Intervention Name(s)

placebo

Other Intervention Name(s)

Lyrica Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

Title

The amount, dose and duration of concomitant pain medication use during study compared to use before study.

Time Frame

2 weeks after randomization

Title

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.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Wahlberg, MD. PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deptartment of Vascular Surgery, Sahlgrenska University Hospital

City

Gothenburg

Country

Sweden

Facility Name

Department of Vascular Surgery, Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

Deptartment of Surgery, South Hospital

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

15254060

Citation

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. doi: 10.1200/JCO.2004.08.141.

Results Reference

background

PubMed Identifier

11877700

Citation

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. doi: 10.1067/mva.2002.120043.

Results Reference

background

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

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