CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
F0434 +1 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/NCT01263132
NCT01263132Phase 3Completed
CompareCT.gov

Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study

Merck KGaA, Darmstadt, Germany·interventional·Posted Dec 20, 2010·Updated Feb 13, 2014

In Brief

A Phase 3 clinical trial evaluating F0434 and Gabapentin for Diabetic Neuropathies and Polyneuropathies. Completed, enrolled 104 participants across 1 site.

Detailed Summary

This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathies, Polyneuropathies
CountriesMexico
CollaboratorsMerck S.A. de C.V., Mexico

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2010
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.5 years ago

Interventions

F0434drug

F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).

Gabapentindrug

Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)