Efficacy and Safety of S (+) - Ibuprofen in the Treatment... | NCT04772781

Studies
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain

NCT04772781

Sponsor

Apsen Farmaceutica S.A.

Status

Completed

Last Update Posted

Jul 17, 2023Actual

Enrollment

177Actual

Phase

Phase 2

Conditions

Low Back Pain, Mechanical
Low Back Pain
Acute Low Back Pain

Interventions

S (+) - Ibuprofen
Ibuflex®

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 2023

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

Jun 3, 2022Actual

Primary Completion Date

May 25, 2023Actual

Completion Date

May 25, 2023Actual

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Feb 26, 2021Actual

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

Jul 13, 2023

Last Update Posted Date

Jul 17, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

177Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S (+) - Ibuprofen	Experimental		Drug: S (+) - Ibuprofen
Ibuflex® - ibuprofen	Active Comparator		Drug: Ibuflex®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S (+) - Ibuprofen	Drug	S (+) - Ibuprofen + placebo of Ibuflex®	S (+) - Ibuprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)	TOTPAR was calculated using data from a 5-point categorical pain relief scale (none = 0, slight = 1, moderate = 2, good = 3, or complete pain relief = 4)	Change from Baseline to 6 hours

Secondary Outcomes

Measure	Description	Time Frame
Adverse events rates between groups		During treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Patient with acute low back pain who responds to the pain period less than or equal to 3 days;

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;
Current or previous history (less than 12 months) of smoking;
Have clinically relevant abnormal laboratory results according to medical evaluation;
Women who are pregnant, lactating, or positive for β - hCG urine test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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
Apsen Farmacêutica S.A.		São Paulo		04753-001	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
D017116	Low Back Pain
D000377	Agnosia
D007249	Inflammation

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007052	Ibuprofen

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided