Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
NCT ID: NCT04647435
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
396 participants
INTERVENTIONAL
2023-05-13
2024-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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APSCTC
Oral tablets every 6h for 3 days
APSCTC
APSCTC + Toragesic® placebo + Tramal® placebo
Toragesic®
Oral tablets every 6h for 3 days
Toragesic®
APSCTC placebo + Toragesic® + Tramal® placebo
Tramal®
Oral tablets every 6h for 3 days
Tramal®
APSCTC placebo + Toragesic® placebo + Tramal®
Interventions
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APSCTC
APSCTC + Toragesic® placebo + Tramal® placebo
Toragesic®
APSCTC placebo + Toragesic® + Tramal® placebo
Tramal®
APSCTC placebo + Toragesic® placebo + Tramal®
Eligibility Criteria
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Inclusion Criteria
* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants who require extraction of impacted mandibular third molar.
Exclusion Criteria
* Previous history of alcohol or drugs abuse diagnosed by DSM-V;
* Previous history of renal failure from moderate to severe;
* Women who are pregnant, lactating, or positive for β - hCG urine test.
18 Years
40 Years
ALL
Yes
Sponsors
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Apsen Farmaceutica S.A.
INDUSTRY
Responsible Party
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Locations
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Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo, Brazil
Countries
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Other Identifiers
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APS001/2020
Identifier Type: -
Identifier Source: org_study_id
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