Clinical Trial: Imipramine and Pregabalin Combination in Painful Polyneuropathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Odense University Hospital

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Odense University Hospital

Dates:
Date Received: January 12, 2010
Date Started: February 2010
Date Completion: March 2013
Last Updated: January 12, 2010
Last Verified: January 2010