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ACTIVE NOT RECRUITING
NCT03774836
PHASE3

Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty

Sponsor: Avenue Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study is evaluating the analgesic efficacy of intravenous (IV) tramadol (AVE-901) compared to placebo in the management of postoperative pain following abdominal surgery.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo and Morphine in the Management of Postoperative Pain Following Abdominoplasty

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2018-12-14

Completion Date

2019-06-30

Last Updated

2019-05-09

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Tramadol

IV Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

DRUG

Morphine

Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

OTHER

Placebo

Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Locations (3)

Lotus Clinical Research

Pasadena, California, United States

Hermann Drive Research

Houston, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States