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Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib).

NCT02982161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2018-05-29

No results posted yet for this study

Summary

The MR308-3501 study is a multicenter, randomised, double-blind, parallel-group study in male and female adult subjects to demonstrate the efficacy of MR308 in the treatment of acute moderate to severe pain after the extraction of at least two third molars requiring bone removal.

Conditions

  • Acute Pain

Interventions

DRUG

MR308

Over-encapsulated tablet, Dosing frequency: two times daily, Mode of administration: oral

DRUG

Tramadol

Over-encapsulated capsule, Dosing frequency: four times daily, Mode of administration: oral

DRUG

Placebo

Capsule, Dosing frequency: four times daily, Mode of administration: oral

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2018-01-04
Completion
2018-01-04

Countries

  • Canada
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT02982161 on ClinicalTrials.gov