Clinical trial
National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Comparator Voltaren® (Diclofenac Sodium 50mg), in the Treatment of Acute Episode of Mechanical Postural Low Back Pain.
NCT02985671 is registered in ClinicalTrials.gov with Ache Laboratorios Farmaceuticos S.A. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Comparator Voltaren® (Diclofenac Sodium 50mg), in the Treatment of Acute Episode of Mechanical Postural Low Back Pain.
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Phase
- Phase 3
- Overall status
- Unknown status
- Start date
- January 31, 2021
- Completion date
- October 31, 2021
- Enrollment
- 110 (estimated)
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.
mechanical low back pain, postural low back pain