Back to resultsEfficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction (CARLOTA)
Primary Purpose
Postsurgical Pain, Third Molar Extraction
Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
APSCTC
Toragesic®
Tramal®
Sponsored by
About this trial
This is an interventional treatment trial for Postsurgical Pain
Eligibility Criteria
Main Inclusion Criteria:
- Males and Females aged 18 to 35 years;
- 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.
Main Exclusion Criteria:
- Known hypersensitivity to the formula components used during the clinical trial;
- 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.
Sites / Locations
- Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
APSCTC
Toragesic®
Tramal®
Arm Description
Oral tablets every 6h for 3 days
Oral tablets every 6h for 3 days
Oral tablets every 6h for 3 days
Outcomes
Primary Outcome Measures
At least 50% of maximum pain relief score (TOTPARmax)
Secondary Outcome Measures
Adverse events incidence and classification
Full Information
NCT ID
NCT04647435
First Posted
November 18, 2020
Last Updated
July 13, 2023
Sponsor
Apsen Farmaceutica S.A.
1. Study Identification
Unique Protocol Identification Number
NCT04647435
Brief Title
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
Acronym
CARLOTA
Official Title
National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
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
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain, Third Molar Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
396 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
APSCTC
Arm Type
Experimental
Arm Description
Oral tablets every 6h for 3 days
Arm Title
Toragesic®
Arm Type
Active Comparator
Arm Description
Oral tablets every 6h for 3 days
Arm Title
Tramal®
Arm Type
Active Comparator
Arm Description
Oral tablets every 6h for 3 days
Intervention Type
Drug
Intervention Name(s)
APSCTC
Intervention Description
APSCTC + Toragesic® placebo + Tramal® placebo
Intervention Type
Drug
Intervention Name(s)
Toragesic®
Intervention Description
APSCTC placebo + Toragesic® + Tramal® placebo
Intervention Type
Drug
Intervention Name(s)
Tramal®
Intervention Description
APSCTC placebo + Toragesic® placebo + Tramal®
Primary Outcome Measure Information:
Title
At least 50% of maximum pain relief score (TOTPARmax)
Time Frame
Change from Baseline to 6 hours
Secondary Outcome Measure Information:
Title
Adverse events incidence and classification
Time Frame
During treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Main Inclusion Criteria:
Males and Females aged 18 to 40 years;
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.
Main Exclusion Criteria:
Known hypersensitivity to the formula components used during the clinical trial;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda Martinez, B.Sc.
Phone
+551156448200
Ext
8404
Email
fernanda.martinez@apsen.com.br
Facility Information:
Facility Name
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
City
Valinhos
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Macedo da Silva, MD
Phone
+55 11 981794142
Email
joyce.macedo@azidusbrasil.com.br
First Name & Middle Initial & Last Name & Degree
Joyce Macedo da Silva, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
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