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Trial record 19 of 46 for:    CYCLOBENZAPRINE

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03127592
Recruitment Status : Unknown
Verified April 2017 by Apsen Farmaceutica S.A..
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
Apsen Farmaceutica S.A.

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.

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: Fixed Dose Combination Drug: Etodolac Drug: Cyclobenzaprine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1
1 active treatment (Fixed Dose Combination) + 2 placebos
Drug: Fixed Dose Combination
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg

Active Comparator: Group 2
1 active treatment (Cyclobenzaprine) + 2 placebos
Drug: Cyclobenzaprine
Individual drug
Other Name: Miosan

Active Comparator: Group 3
1 active treatment (Etodolac) + 2 placebos
Drug: Etodolac
Individual drug
Other Name: Flancox

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Edema [ Time Frame: 4 hours ]
    Absence of edema after 4 hours of drug administration and at the end of treatment

  3. Mandibula constriction [ Time Frame: 4 hours ]
    Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Apsen Farmaceutica S.A. Identifier: NCT03127592     History of Changes
Other Study ID Numbers: ETCAPS0317OR-III
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Signs and Symptoms
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors