NCT03664921

Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy

A Phase II Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study Investigating the Safety and Efficacy of Omnitram in Diabetic Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Syntrix Biosystems, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.

Detailed description

A multi-centered, randomized, double-blind, placebo-controlled, two-period cross-over study to compare the safety and efficacy of Omnitram (30 mg to 120 mg daily) and placebo in patients with painful diabetic polyneuropathy. For subjects receiving treatment for neuropathic pain prior to study enrollment, their treatment will be tapered and stopped at least 2 weeks before they will be enrolled. Approximately fifty subjects will be randomized in a double-blind manner to a 4-week treatment period of Omnitram or placebo. After a washout of at least one week, patients will cross-over to the other treatment for a second 4 week treatment period with Omnitram or placebo. During the first two weeks of each treatment period, guided by efficacy and tolerability, the dose will be increased from 3 tablets to 12 tablets per day given in three equal doses at approximately at 8 am, 2 pm and 8 pm (i.e., if the tablet is Omnitram, 30, 60, 90 or 120 mg/day). During the final two weeks of the treatment period, the doses will be kept constant at the highest tolerated titrated dose. Up to six tablets daily of 500 mg oral acetaminophen can be used as rescue medication except on the last 4 days of each treatment segment (Days 26, 27, 28, and 29).

Conditions

• Diabetic Neuropathies
• Neuropathic Pain
• Pain, Chronic

Interventions

Type	Name	Description
DRUG	Omnitram Oral Tablet	Administered three times daily for 28 consecutive days.
DRUG	Placebo Oral Tablet	Administered three times daily for 28 consecutive days.

Timeline

• Start date: 2018-11-15
• Primary completion: 2020-08-17
• Completion: 2020-08-17
• First posted: 2018-09-11
• Last updated: 2021-09-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study