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 | Terminated Phase 3 DMC

• 1 other identifier: ETCAPS0317OR-III
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Superiority of the Fixed Dose Combination versus Isolated active substances

  The Primary outcome will be accessed by the individual response rate in relation to the pain intensity calculated by the Visual Analogic Scale (VAS) scale performed after 4 hours of administration of the first dose of medicines

  4 hours

Secondary Outcomes (4)

• Individual response rate

  6h, 12h, 24h, 48h and 72h

• Edema

  4 hours

• Mandibula constriction

  4 hours

• Use of rescue medication

  3 days

Study Arms (3)

Group 1

EXPERIMENTAL

1 active treatment (Fixed Dose Combination) + 2 placebos

Drug: Fixed Dose Combination

Group 2

ACTIVE COMPARATOR

1 active treatment (Cyclobenzaprine) + 2 placebos

Drug: Cyclobenzaprine

Group 3

ACTIVE COMPARATOR

1 active treatment (Etodolac) + 2 placebos

Drug: Etodolac

Interventions

Fixed Dose Combination DRUG

Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg

Group 1

Etodolac DRUG

Individual drug

Also known as: Flancox

Group 3

Cyclobenzaprine DRUG

Individual drug

Also known as: Miosan

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery

You may not qualify if:

• Presence of any event and / or pathology at the site of interest that may interfere with and contraindicate the performance of the surgical procedure at the discretion of the Investigator, including periodontitis, odontogenic tumors or cysts (associated or not with the third molar), trauma, presence of Inflammation and / or infection;
• Present or past history of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological event;
• Previous diagnosis of alcohol and drug abuse defined by DSM-V;
• Current or past history (for less than 12 months) of smoking;
• Use of illicit drugs;
• History of bleeding / bleeding or coagulation disorders, gastric ulcer and / or active peptic hemorrhage;
• Any finding of clinical (clinical / physical), laboratory or cardiac evaluation (ECG) observation that is interpreted by the investigating physician as a risk to the participant;
• Use of drugs that potentially interfere with the kinetics / dynamics of acetaminophen or any other medicinal product considered clinically significant by the Investigator;
• Known hypersensitivity to the active principles used during the study (etodolac and cyclobenzaprine);
• Women in gestation or breastfeeding, as well as women who present a positive pregnancy test (β - hCG) during the study screening / selection period;
• Professionals directly involved in the realization of the present study and their relatives;
• Participant of the research that has participated in clinical study protocols in the last 12 (twelve) months, unless the Investigator deems that there may be direct benefit to it.

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (1)

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Valinhos, São Paulo, 13271-130, Brazil

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Etodolac; cyclobenzaprine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoleacetic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: October 5, 2020
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)