Critical Limb IschemiaPhase 4NCT00403780
Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
A Phase 4 study testing pregabalin in people with Critical Limb Ischemia and Arterial Occlusive Disease, run by Karolinska Institutet at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Limb Ischemia, Arterial Occlusive Disease, Pain
- What is being tested?
- pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 3 sitesSweden
- Study dates
- Jun 2006to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Deptartment of Vascular Surgery, Sahlgrenska University Hospital
Gothenburg
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, SE-171 76
Deptartment of Surgery, South Hospital
Stockholm
About this study
Official title: Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Critical Limb Ischemia, Arterial Occlusive Disease, Pain, Ischemia
- Being tested
- pregabalin, placebo
- 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
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Arterial Occlusive Diseases, Pain, Ischemia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
Also called Capsule Lyrica 75mg. Manufacturer company: Pfizer
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.
placeboDrug
Also called Lyrica 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Active intervention with pregabalin Receives: Drug: pregabalin |
| B | Placebo comparator | placebo arm with capsule Lyrica Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 2, 4 and 8 weeks after randomization
Secondary outcomes (3)
Improvement in the Short Form 36 (SF-36) parameter "bodily pain".
Measured: 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.
Measured: 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.
Measured: up to 8 weeks, as long as patients is in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2013
- Study completionJul 2015
Why it stopped: low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Jonas Malmstedt, Karolinska Institutet
- Investigators
- Eric Wahlberg, MD. PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403780
- Sponsor's protocol ID
- PREPARED_00
- Status last verified
- Jun 2018
- First submitted
- 24 Nov 2006
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1200/JCO.2004.08.141.
PubMed 15254060Hultgren 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.
PubMed 11877700
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00403780
- Acronym / sponsor ID
- PREPARED_00
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion rate
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Jun 2006
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: pregabalinActive intervention with pregabalin |
| B | Placebo comparator | Drug: placeboplacebo arm with capsule Lyrica Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Age < 55 years
- Women of childbearing potential
- Patients already medicating with Pregabalin or Gabapentin
- Creatinine clearance <30ml/min
- Amputation necessary within two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalinAlso: Capsule Lyrica 75mg. Manufacturer company: PfizerCapsule 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. | Drug | A |
| placeboAlso: Lyrica PlaceboCapsule 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. | Drug | B |
Primary outcome
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
3 secondary outcomes
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.
The amount, dose and duration of concomitant pain medication use during study compared to use before study.
Time frame: 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.
Time frame: up to 8 weeks, as long as patients is in the study.
Results and safety
The study was stopped early (reason given: low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Background: PubMed 15254060Caraceni 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.
- Background: PubMed 11877700Hultgren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Wahlberg, MD. PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pregabalin in people with Critical Limb Ischemia and Arterial Occlusive Disease, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.