Clinical Trials Logo
  1. Home
  2. Neuropathic Pain
  3. NCT03664921

Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy

Neuropathic Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03664921
Study type Interventional
Source Syntrix Biosystems, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 15, 2018
Completion date August 17, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04699734 - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Completed NCT05235191 - Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies Phase 3
Completed NCT05845177 - Persistent Pain After Hip Replacement
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Not yet recruiting NCT05949554 - Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.
Withdrawn NCT05052645 - Ear Acupuncture for Neuropathic Pain N/A
Completed NCT02930551 - Neuromas as the Cause of Pain N/A
Completed NCT02824588 - Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain N/A
Completed NCT02866396 - Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
Active, not recruiting NCT02560545 - Cannabinoids Effects on the Pain Modulation System N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02099890 - The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury Phase 3
Not yet recruiting NCT02246517 - The Effect of N2O on Chronic Neuropathic Pain Patients Phase 0
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Completed NCT01718821 - Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients N/A
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01669967 - The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin N/A
Completed NCT01207596 - Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain Phase 4
Completed NCT01201317 - A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy Phase 2