Efficacy and Safety of APSCTC for the Treatment of Postsu... | NCT04647435

Studies
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction

NCT04647435

Sponsor

Apsen Farmaceutica S.A.

Status

Completed

Last Update Posted

Feb 7, 2025Actual

Enrollment

396Actual

Phase

Phase 3

Conditions

Postsurgical Pain
Third Molar Extraction

Interventions

APSCTC
Toragesic®
Tramal®

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2023Actual

Primary Completion Date

Oct 4, 2024Actual

Completion Date

Oct 4, 2024Actual

First Submitted Date

Nov 18, 2020

First Submission Date that Met QC Criteria

Nov 23, 2020

First Posted Date

Dec 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2025

Last Update Posted Date

Feb 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

396Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
APSCTC	Experimental	Oral tablets every 6h for 3 days	Drug: APSCTC
Toragesic®	Active Comparator	Oral tablets every 6h for 3 days	Drug: Toragesic®
Tramal®	Active Comparator	Oral tablets every 6h for 3 days	Drug: Tramal®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
APSCTC	Drug	APSCTC + Toragesic® placebo + Tramal® placebo	APSCTC
Toragesic®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
At least 50% of maximum pain relief score (TOTPARmax)		Change from Baseline to 6 hours

Secondary Outcomes

Measure	Description	Time Frame
Adverse events incidence and classification		During treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.		Valinhos	São Paulo		Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014147	Tramadol

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided