CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 811 enrolled
Drug / intervention
Duloxetine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01089556
NCT01089556Phase 3Completed
CompareCT.gov

Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"

Eli Lilly and Company·interventional·Posted Mar 18, 2010·Updated Jan 24, 2013

In Brief

A Phase 3 clinical trial evaluating Duloxetine, Pregabalin, and 1 other intervention for Diabetic Neuropathy, Painful. Completed, enrolled 811 participants across 54 sites in 16 countries.

Detailed Summary

This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesAustralia, Canada, Croatia, France, Germany, Greece, Italy, Mexico, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
CollaboratorsBoehringer Ingelheim

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2010
Enrollment StartMar 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.3 years ago

Interventions

Duloxetinedrug

Administered orally

Pregabalindrug

Administered orally

Placebodrug

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks