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

NCT03774836 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-05-09

No results posted yet for this study

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.

Conditions

  • Pain Management

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

Sponsors & Collaborators

  • Avenue Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2019-05-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03774836 on ClinicalTrials.gov