Trial intelligence / Profile preview

Indantadol in Diabetic Peripheral Neuropathic Pain

NCT00794430Phase 2

Key facts

Status: Completed
Start: Dec 2008
Primary completion: Dec 2009
Countries: 4
Sponsor: Vernalis
Modality: Small Molecules

Drugs: indantadol
Conditions: diabetic polyneuropathy (DPN)

Overview

Phase 2, randomised, double-blind trial in diabetic polyneuropathy (DPN) comparing V3381 with Placebo (2 arms). Primary endpoint: Safety and Tolerability of V3381 at 17 weeks. Started Dec 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

V3381
Indantadol titrated 100-400 mg bid
Placebo
Matching placebo

Who it enrols

Patients with diabetic peripheral neuropathic pain for at least 6 months, stable diabetes medication, and pain score between 4 and 9.

Endpoints

Primary

Safety and Tolerability of V338117 weeks

Secondary

Efficacy of V3381 in Diabetic Peripheral Neuropathic Pain17 weeks
Modified Brief Pain Inventory for diabetic painful neuropathy13 weeks
Neuropathic Pain Symptom Inventory13 weeks
Clinical Global Impression13 weeks
Medical Outcomes Survey Short Form-36 Version 2Week 13

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