- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03127592
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)
February 7, 2023 updated by: Apsen Farmaceutica S.A.
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fernanda Martinez
- Phone Number: 8404 +551156448200
- Email: fernanda.martinez@apsen.com.br
Study Locations
-
-
São Paulo
-
Valinhos, São Paulo, Brazil, 13271-130
- Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
1 active treatment (Fixed Dose Combination) + 2 placebos
|
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
|
ACTIVE_COMPARATOR: Group 2
1 active treatment (Cyclobenzaprine) + 2 placebos
|
Individual drug
Other Names:
|
ACTIVE_COMPARATOR: Group 3
1 active treatment (Etodolac) + 2 placebos
|
Individual drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superiority of the Fixed Dose Combination versus Isolated active substances
Time Frame: 4 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual response rate
Time Frame: 6h, 12h, 24h, 48h and 72h
|
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
|
6h, 12h, 24h, 48h and 72h
|
Edema
Time Frame: 4 hours
|
Absence of edema after 4 hours of drug administration and at the end of treatment
|
4 hours
|
Mandibula constriction
Time Frame: 4 hours
|
Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment
|
4 hours
|
Use of rescue medication
Time Frame: 3 days
|
Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 5, 2020
Primary Completion (ACTUAL)
July 26, 2022
Study Completion (ACTUAL)
July 26, 2022
Study Registration Dates
First Submitted
April 17, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (ACTUAL)
April 25, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Cyclooxygenase 2 Inhibitors
- Neuromuscular Agents
- Muscle Relaxants, Central
- Etodolac
- Cyclobenzaprine
Other Study ID Numbers
- ETCAPS0317OR-III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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