Imipramine and Pregabalin Combination in Painful Polyneuropathy

NCT01047488

Last updated date
Study Location
Department of Neurology, Aalborg Hospital
Aalborg, , DK-9000, Denmark
Contact
+45 65412471

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Polyneuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- For other secondary polyneuropathies: stable for at least 6 months.

- For fertile females: adequate anticonceptive treatment.

- Written informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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PolyneuropathyImipramine and Pregabalin Combination in Painful Polyneuropathy
NCT01047488
  1. Aalborg,
  2. Odense,
  3. Århus,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Imipramine and Pregabalin Combination in Painful Polyneuropathy
Official Title  ICMJE Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
Brief 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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polyneuropathy
Intervention  ICMJE
  • Drug: Imipramine
    Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks
    Other Name: Imipramin DAK
  • Drug: Pregabalin
    Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
    Other Name: Lyrica
  • Drug: Imipramine, pregabalin
    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
    Other Names:
    • Imipramin DAK
    • Lyrica
  • Drug: Placebo
    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 Arms  ICMJE
  • Active Comparator: Imipramine
    Imipramine tablets and placebo capsules to pregabalin
    Intervention: Drug: Imipramine
  • Active Comparator: Pregabalin
    Pregabalin capsules and placebo tablets to imipramine
    Intervention: Drug: Pregabalin
  • Experimental: Imipramine plus pregabalin
    Imipramine tablets and pregabalin capsules
    Intervention: Drug: Imipramine, pregabalin
  • Placebo Comparator: Placebo
    Placebo tablets to imipramine and placebo capsules to pregabalin
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2010)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • For other secondary polyneuropathies: stable for at least 6 months.
  • For fertile females: adequate anticonceptive treatment.
  • Written informed consent.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01047488
Other Study ID Numbers  ICMJE tcapgbcomb1
2009-013642-80 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Søren Hein Sindrup, Department of Neurology, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Pfizer
  • Nycomed
Investigators  ICMJE
Study Chair:Søren H. Sindrup, MDDepartment of Neurology, Odense University Hospital
Principal Investigator:Jakob V. Holbech, MDDepartment of Neurology, Odense University Hospital
PRS Account Odense University Hospital
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP