PolyneuropathyPhase 4NCT01047488
Imipramine and Pregabalin Combination in Painful Polyneuropathy
A Phase 4 study testing Imipramine, Pregabalin and Imipramine, pregabalin in people with Polyneuropathy, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Polyneuropathy
- What is being tested?
- Imipramine, Pregabalin and Imipramine, pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesDenmark
- Study dates
- Feb 2010to Mar 2013
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 - 85 years.
- Characteristic symptoms of polyneuropathy for at least 6 months.
- Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
- Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
- Pain present at least 4 days a week.
- For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months.
Show all 9Show fewer
- For other secondary polyneuropathies: stable for at least 6 months.
- For fertile females: adequate anticonceptive treatment.
- Written informed consent.
Who cannot join
- Other cause of pain.
- Contraindications against imipramine.
- Allergic reactions towards imipramine or pregabalin.
- Known adverse reactions during imipramine or pregabalin treatment.
- Pregnancy.
- Severe systemic disease.
- Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor.
- Inability to follow study protocol.
Trial locations and contacts
3 sites in 1 country.
Jakob V. Holbech, MD contact
Denmark3 sites
Department of Neurology, Aalborg Hospital
Aalborg, DK-9000
Flemming W. Bach, MD, +45 99321928, fwb@rn.dk
Flemming W. Bach, MD
Department of Neurology, Aarhus University Hospital
Aarhus, DK-8000
Troels S. Jensen, MD, +45 89494137, tsjensen@ki.au.dk
Nanna Finnerup, MD, finnerup@ki.au.dk
Department of Neurology, Odense University Hospital
Odense, DK-5000
Søren H. Sindrup, MD, +45 65412471, soeren.sindrup@ouh.regionsyddanmark.dk
Jakob V. Holbech, MD, Holbech@dadlnet.dk
About this study
Official title: Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.
This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.
- Conditions
- Polyneuropathy
- Being tested
- Imipramine, Pregabalin, Imipramine, pregabalin, Placebo
- Keywords
- polyneuropathy, neuropathic pain, treatment
- Medical subject headings
- Polyneuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipramineDrug
Also called Imipramin DAK
Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks
PregabalinDrug
Also called Lyrica
Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
Imipramine, pregabalinDrug
Also called Imipramin DAK, Lyrica
Imipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
PlaceboDrug
Placebo tablets to imipramine 25 mg, 3 or 1 tablet evening, daily, 5 weeks Placebo capsules to pregabalin 75 mg, 2 capsules daily, daily, 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imipramine | Active comparator | Imipramine tablets and placebo capsules to pregabalin Receives: Drug: Imipramine |
| Pregabalin | Active comparator | Pregabalin capsules and placebo tablets to imipramine Receives: Drug: Pregabalin |
| Imipramine plus pregabalin | Experimental | Imipramine tablets and pregabalin capsules Receives: Drug: Imipramine, pregabalin |
| Placebo | Placebo comparator | Placebo tablets to imipramine and placebo capsules to pregabalin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain intensity as measured by numeric rating scale 0-10 points.
Measured: Median of ratings from last week of each treatment period
Secondary outcomes (7)
Verbal pain relief scale with 6 classes
Measured: End of each treatment period
Specific pain symptom rated by numeric rating scales 0-10 points
Measured: Median of ratings from last week of each treatment period
Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points
Measured: End of each treatment period
Sleep disturbance as measured by numeric rating scale 0-10 points
Measured: Median of ratings from last week of each treatment period
Consumption of escape medication (number of tablets of paracetamol)
Measured: Total consumption during last week of each treatment period
Health related quality of life (SF-36)
Measured: End of each treatment period
Major Depression Inventory (MDI)
Measured: End of each treament period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Nycomed
- Investigators
- Søren H. Sindrup, MD, Study chair, Department of Neurology, Odense University HospitalJakob V. Holbech, MD, Principal investigator, Department of Neurology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047488
- Sponsor's protocol ID
- tcapgbcomb1
- Other IDs
- 2009-013642-80, 2009
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
- ClinicalTrials.gov ID
- NCT01047488
- Acronym / sponsor ID
- tcapgbcomb1
- Conditions
- Polyneuropathy
- Keywords
- polyneuropathy, neuropathic pain, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Pfizer, Nycomed
- Study start
- Feb 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 13 Jan 2010 (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.
Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.
This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Imipramine | Active comparator | Drug: ImipramineImipramine tablets and placebo capsules to pregabalin |
| Pregabalin | Active comparator | Drug: PregabalinPregabalin capsules and placebo tablets to imipramine |
| Imipramine plus pregabalin | Experimental | Drug: Imipramine, pregabalinImipramine tablets and pregabalin capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets to imipramine and placebo capsules to pregabalin |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 20 - 85 years.
- Characteristic symptoms of polyneuropathy for at least 6 months.
- Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
- Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
- Pain present at least 4 days a week.
Key exclusion criteria (8 listed)
- Other cause of pain.
- Contraindications against imipramine.
- Allergic reactions towards imipramine or pregabalin.
- Known adverse reactions during imipramine or pregabalin treatment.
- Pregnancy.
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 |
|---|---|---|
| ImipramineAlso: Imipramin DAKTablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks | Drug | Imipramine |
| PregabalinAlso: LyricaCapsule 75 mg, 2 capsules twice daily, daily, 5 weeks | Drug | Pregabalin |
| Imipramine, pregabalinAlso: Imipramin DAK, LyricaImipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks | Drug | Imipramine plus pregabalin |
| PlaceboPlacebo tablets to imipramine 25 mg, 3 or 1 tablet evening, daily, 5 weeks Placebo capsules to pregabalin 75 mg, 2 capsules daily, daily, 5 weeks | Drug | Placebo |
Primary outcome
Total pain intensity as measured by numeric rating scale 0-10 points.
Time frame: Median of ratings from last week of each treatment period
7 secondary outcomes
Verbal pain relief scale with 6 classes
Time frame: End of each treatment period
Specific pain symptom rated by numeric rating scales 0-10 points
Time frame: Median of ratings from last week of each treatment period
Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points
Time frame: End of each treatment period
Sleep disturbance as measured by numeric rating scale 0-10 points
Time frame: Median of ratings from last week of each treatment period
Consumption of escape medication (number of tablets of paracetamol)
Time frame: Total consumption during last week of each treatment period
Health related quality of life (SF-36)
Time frame: End of each treatment period
Major Depression Inventory (MDI)
Time frame: End of each treament period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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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.
Jakob V. Holbech, MD contact
Søren H. Sindrup, MD study chair
Department of Neurology, Odense University Hospital
Jakob V. Holbech, MD principal investigator
Department of Neurology, Odense University Hospital
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 Imipramine, Pregabalin and Imipramine, pregabalin in people with Polyneuropathy, run by Odense University Hospital at 3 sites in Denmark.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Jan 2010. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Søren H. Sindrup, MD (+45 65412471, soeren.sindrup@ouh.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pain intensity as measured by numeric rating scale 0-10 points. (time frame: Median of ratings from last week of each treatment period). 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 13 Jan 2010.