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COMPLETEDPHASE3

Evaluation of N1539 Following Abdominoplasty Surgery

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Abdominoplasty Surgery

NCT02678286•Baudax Bio

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntarily provide written informed consent.
•Male or female between 18 and 75 years of age, inclusive.
•Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.
•Be American Society of Anesthesiology (ASA) physical class 1 or 2.
•Female subject are eligible only if all the following apply:
•* Not pregnant;
•* Not lactating;
•* Not planning to become pregnant during the study;
•* Commit to the use of an acceptable form of birth control for the duration of the study.
•Have a body mass index ≤35 kg/m2
+1 more criteria

Exclusion Criteria

•Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
•Have a clinically significant abnormal clinical laboratory test value.
•Have history of or positive test results for HIV, or hepatitis B or C.
•Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
•Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months
•Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
•Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
•Have a known bleeding disorder or be taking agents affecting coagulation.
•Have another painful physical condition that may confound the assessments of post operative pain.
•Have evidence of a clinically significant 12 lead ECG abnormality.
+10 more criteria

Locations (4)

Lotus Clinical Research, LLC

Pasadena, California, United States

HD Research

Bellaire, Texas, United States

Research Concepts

Bellaire, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

October 1, 2016

Completion Date

November 1, 2016

Last Updated

February 14, 2018

Enrollment

219

ACTUAL participants

Conditions

Pain, Post-operative

Interventions

N1539

DRUG

Intravenous Placebo

DRUG

Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction

NCT06484439

Pain, Post-operativeThird Molar+2 more

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UNKNOWNPHASE2

Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery

NCT05950152

Pain, Post-operative

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of N1539 Following Abdominoplasty Surgery

Inclusion Criteria

Exclusion Criteria

Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction

Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery