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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 (FDCETCB-III)

Primary Purpose

Pain, Acute

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Fixed Dose Combination
Etodolac
Cyclobenzaprine
Sponsored by
Apsen Farmaceutica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

1 active treatment (Fixed Dose Combination) + 2 placebos

1 active treatment (Cyclobenzaprine) + 2 placebos

1 active treatment (Etodolac) + 2 placebos

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Individual response rate
Individual response rate in relation to the evaluation of pain intensity calculated through the Visual Analogic Scale (VAS) measure in times 6h, 12h, 24h, 48h and 72h
Edema
Absence of edema after 4 hours of drug administration and at the end of treatment
Mandibula constriction
Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment
Use of rescue medication
Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group

Full Information

First Posted
April 17, 2017
Last Updated
February 7, 2023
Sponsor
Apsen Farmaceutica S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03127592
Brief Title
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
Acronym
FDCETCB-III
Official Title
Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox® 400 mg And Miosan® 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulty
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apsen Farmaceutica S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
1 active treatment (Fixed Dose Combination) + 2 placebos
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
1 active treatment (Cyclobenzaprine) + 2 placebos
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
1 active treatment (Etodolac) + 2 placebos
Intervention Type
Drug
Intervention Name(s)
Fixed Dose Combination
Intervention Description
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
Intervention Type
Drug
Intervention Name(s)
Etodolac
Other Intervention Name(s)
Flancox
Intervention Description
Individual drug
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine
Other Intervention Name(s)
Miosan
Intervention Description
Individual drug
Primary Outcome Measure Information:
Title
Superiority of the Fixed Dose Combination versus Isolated active substances
Description
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
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Individual response rate
Description
Individual response rate in relation to the evaluation of pain intensity calculated through the Visual Analogic Scale (VAS) measure in times 6h, 12h, 24h, 48h and 72h
Time Frame
6h, 12h, 24h, 48h and 72h
Title
Edema
Description
Absence of edema after 4 hours of drug administration and at the end of treatment
Time Frame
4 hours
Title
Mandibula constriction
Description
Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment
Time Frame
4 hours
Title
Use of rescue medication
Description
Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery Exclusion Criteria: 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.
Facility Information:
Facility Name
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
City
Valinhos
State/Province
São Paulo
ZIP/Postal Code
13271-130
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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