Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-31 @ 8:58 AM
Study NCT ID:
NCT05013567
Status:
UNKNOWN
Last Update Posted:
2022-03-21
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain
Sponsor:
Brainfarma Industria Química e Farmacêutica S/A
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Parallel, Phase III Superiority Clinical Trial to Evaluate the Efficacy and Safety of Ibuprofen Gel Compared With Placebo in the Treatment of Acute Musculoskeletal Pain
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGEL
Brief Summary:
Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.
Detailed Description:
This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves.
It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis.
The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.
It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis.
The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: