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Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.

NCT03108482 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2019-01-24

Study results available
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Summary

This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to tramadol and to celecoxib for the management of moderate to severe acute post-operative pain for 48 hours after bunionectomy.

Conditions

  • Acute Post-surgical Pain

Interventions

DRUG

Co-crystal E-58425 (Tramadol/Celecoxib)

Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.

DRUG

Tramadol (Ultram®)

Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.

DRUG

Celecoxib (Celebrex®)

Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.

DRUG

Placebo

Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Esteve Pharmaceuticals, S.A.

    lead INDUSTRY

Principal Investigators

  • Jesus Cebrecos, MD, MBA · Esteve Pharmaceuticals, S.A.

  • Michael Kuss · Premier Research Group plc

  • Ira J Gottlieb, DPM · Chesapeake Research Group, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2017-11-09
Completion
2017-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03108482 on ClinicalTrials.gov