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Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

NCT03127592 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-02-09

No results posted yet for this study

Summary

This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after impacted third molar extraction.

Conditions

  • Pain, Acute

Interventions

DRUG

Fixed Dose Combination

Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg

DRUG

Etodolac

Individual drug

DRUG

Cyclobenzaprine

Individual drug

Sponsors & Collaborators

  • Apsen Farmaceutica S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2022-07-26
Completion
2022-07-26

Countries

  • Brazil

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 NCT03127592 on ClinicalTrials.gov