Trials / Completed
CompletedNCT01471899
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- EMS · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain treatment.
Detailed description
* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial. * Experiment duration: 04 days. * 03 visits (days 0, 2 and 4). * Efficacy will be evaluated for back pain relief based on visual analogic scale. * Adverse events evaluation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ketorolac Tromethamine | 10 drops each 8 hours for 4 days. |
| DRUG | Naproxen | 2 tablets every 8 hours for 4 days |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2013-12-01
- Completion
- 2014-04-30
- First posted
- 2011-11-16
- Last updated
- 2021-02-24
Source: ClinicalTrials.gov record NCT01471899. Inclusion in this directory is not an endorsement.