PainNCT01359514
Mechanism-based Choice of Therapy for Neuropathic Pain
A study testing Pregabalin and Duloxetine in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Mechanism-based choice of therapy for neuropathic pain: Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Pregabalin and Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Jan 2014
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients planned for thoracotomy
Who cannot join
- age below 18 and above 75 years
- patients with psychiatric or cognitive dysfunction precluding use of psychophysics
- those who cannot communicate in Hebrew
- patients with existing thoracic or other current chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?
Mechanism-based choice of therapy for neuropathic pain:
Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?
Read the detailed description
Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.
- Conditions
- Pain
- Being tested
- Pregabalin, Duloxetine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Calcium-channel blocker
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
DuloxetineDrug
Also called SSNRI
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Active comparator | Not described Receives: Drug: Pregabalin |
| Pregabalin | Active comparator | Not described Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pain
The pain relief will be achieved by treatment with duloxetine or pregabalin. We propose that the patients with deficient pain inhibition (As assessed by conditioned pain modulation lab test) will have better drug efficacy of cymbalta which restores the deficient level of serotonin and noradrenalin. In turn, pregabalin will be more effective in patients with enhance central sensitization of pain as measured by temporal summation assessment. In line, CPM and TS will be modulated by the treatment, in parallel with the analgesic effect.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d_yarnitsky, Rambam Health Care Campus
- Investigators
- David Yarnitsky, Professor, Principal investigator, Rambam Health Care CampusMichal Granot, PhD, Study director, Haifa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359514
- Sponsor's protocol ID
- PostOperativePain05CTIL
- Status last verified
- Oct 2017
- First submitted
- 10 Jul 2010
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?
- ClinicalTrials.gov ID
- NCT01359514
- Acronym / sponsor ID
- PostOperativePain05CTIL
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 May 2011 (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.
Mechanism-based choice of therapy for neuropathic pain:
Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?
Detailed description
Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Active comparator | Drug: Pregabalin |
| Pregabalin | Active comparator | Drug: Duloxetine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients planned for thoracotomy
Key exclusion criteria (4 listed)
- age below 18 and above 75 years
- patients with psychiatric or cognitive dysfunction precluding use of psychophysics
- those who cannot communicate in Hebrew
- patients with existing thoracic or other current chronic pain
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: Calcium-channel blockerInitial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks | Drug | Duloxetine |
| DuloxetineAlso: SSNRIInitial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks | Drug | Pregabalin |
Primary outcome
clinical pain
Time frame: One year
The pain relief will be achieved by treatment with duloxetine or pregabalin. We propose that the patients with deficient pain inhibition (As assessed by conditioned pain modulation lab test) will have better drug efficacy of cymbalta which restores the deficient level of serotonin and noradrenalin. In turn, pregabalin will be more effective in patients with enhance central sensitization of pain as measured by temporal summation assessment. In line, CPM and TS will be modulated by the treatment, in parallel with the analgesic effect.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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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.
David Yarnitsky, Professor principal investigator
Rambam Health Care Campus
Michal Granot, PhD study director
Haifa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Duloxetine in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical pain (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2017.