NCT04647435

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

May 13, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2024

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

November 18, 2020

Last Update Submit

February 6, 2025

Conditions

Postsurgical PainThird Molar Extraction

Outcome Measures

Primary Outcomes (1)

  • At least 50% of maximum pain relief score (TOTPARmax)

    Change from Baseline to 6 hours

Secondary Outcomes (1)

  • Adverse events incidence and classification

    During treatment

Study Arms (3)

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

APSCTCDRUG

APSCTC + Toragesic® placebo + Tramal® placebo

APSCTC
Toragesic®DRUG

APSCTC placebo + Toragesic® + Tramal® placebo

Toragesic®
Tramal®DRUG

APSCTC placebo + Toragesic® placebo + Tramal®

Tramal®

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 1, 2020

Study Start

May 13, 2023

Primary Completion

October 4, 2024

Study Completion

October 4, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)