Study Stopped
low inclusion rate
Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study
1 other identifier
interventional
18
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2006
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 24, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJune 15, 2018
June 1, 2018
6.9 years
November 24, 2006
June 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
1, 2, 4 and 8 weeks after randomization
Secondary Outcomes (3)
Improvement in the Short Form 36 (SF-36) parameter "bodily pain".
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.
The amount, dose and duration of concomitant pain medication use during study compared to use before study.
2 weeks after randomization
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.
up to 8 weeks, as long as patients is in the study.
Study Arms (2)
A
ACTIVE COMPARATORActive intervention with pregabalin
B
PLACEBO COMPARATORplacebo arm with capsule Lyrica Placebo
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
Study Sites (3)
Deptartment of Vascular Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, SE-171 76, Sweden
Deptartment of Surgery, South Hospital
Stockholm, Sweden
Related Publications (2)
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.
PMID: 15254060BACKGROUNDHultgren 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.
PMID: 11877700BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Wahlberg, MD. PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 24, 2006
First Posted
November 27, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2013
Study Completion
July 1, 2015
Last Updated
June 15, 2018
Record last verified: 2018-06