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Clinical trial

National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With At Least Moderate Mechanical Acute Low Back Pain

ID
Name
APS002/2020
Description
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.
Trial arms
Trial start
2022-06-03
Estimated PCD
2023-05-25
Trial end
2023-05-25
Status
Completed
Phase
Early phase I
Treatment
S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuflex®
Arms:
S (+) - Ibuprofen
Ibuflex®
Ibuflex® + placebo of S (+) - Ibuprofen
Arms:
Ibuflex® - ibuprofen
Size
177
Primary endpoint
At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)
Change from Baseline to 6 hours
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 177, 'type': 'ACTUAL'}}
Updated at
2023-07-17

1 organization

2 products

3 indications

Organization
Apsen Farmaceutica
Product
Ibuprofen
Indication
Low Back Pain
Indication
Mechanically-induced disease
Indication
Acute Low Back Pain
Product
Ibuflex®