Clinical Trial: Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Multicenter Study With 500 mg QD of TRO19622 Versus Placebo in Patients With Painful Peripheral Diabetic Neuropathy

Brief Summary: The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO daily for 6 weeks compared to placebo administered PO daily in patients with painful peripheral diabetic neuropathy.

Detailed Summary:

Diabetic peripheral neuropathic pain (DPNP) affects approximately 11% of patients with diabetic peripheral neuropathy (DPN). Diabetic neuropathy as the underlying disease is the most common long-term complication of diabetes mellitus estimated to be experienced by a majority of patients at least in a mild manner.

Many patients with (DPNP) do not respond adequately to any individual treatment option. None of the various treatments used can be considered a cure. As a result, although a variety of drugs are available for the treatment of diabetic neuropathic pain, there is a strong need to develop new drugs with greater efficacy and/or fewer adverse effects.

The primary objective of the study is to compare the effect of TRO19622 versus placebo on the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period.

Secondary objectives are to compare the efficacy on neuropathic pain, impact on emotional functioning, safety profile, pain time course, and response rate of TRO19622 versus placebo. Additionally, the pharmacokinetics of TRO19622 will be assessed.


Sponsor: Hoffmann-La Roche

Current Primary Outcome: Effect of TRO19622 versus Placebo on the mean 24h neuropathic pain score on the Likert numerical rating scale. [ Time Frame: During the last 7 days of the 6-week treatment period ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 24h Pain time course [ Time Frame: Duration of study (within 11weeks after screening) ]
  • Analysis for treatment effects: SF-MPQ, SF-BPI, SF36, POMS, Global Impression of Change (Patient / Investigator) [ Time Frame: Within 6 weeks of treatment ]
  • Adverse events [ Time Frame: During the course of the study. ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: June 22, 2007
Date Started: May 2007
Date Completion:
Last Updated: November 21, 2016
Last Verified: November 2016