Trials / Completed
CompletedNCT01089556
A Study in Painful Diabetic Neuropathy
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"
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 811 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duloxetine | Administered orally |
| DRUG | Pregabalin | Administered orally |
| DRUG | Placebo | Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2010-03-18
- Last updated
- 2013-01-24
- Results posted
- 2012-12-04
Locations
54 sites across 16 countries: Australia, Canada, Croatia, France, Germany, Greece, Italy, Mexico, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01089556. Inclusion in this directory is not an endorsement.