Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Recruitment status was: Not yet recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment|
- Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS). [ Time Frame: 4 days ] [ Designated as safety issue: No ]
The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit.
The response rate is calculated using the following formula:
Response rate = (VASvi - VASvf) / VASvi
- VASvi: VAS in the first visit;
- VASvf: VAS at the last visit;
- Safety will be evaluated by the adverse events occurrences [ Time Frame: day 4 ] [ Designated as safety issue: Yes ]Adverse events will be collected and followed in order to evaluate safety and tolerability
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Naproxen
2 tablets every 8 hours for 4 days.
2 tablets every 8 hours for 4 days
Experimental: Ketorolac Tromethamine
10 drops every 8 hours for 4 days
Drug: Ketorolac Tromethamine
10 drops each 8 hours for 4 days.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471899
|Principal Investigator:||Pérola Plaper, MD||Instituto do Coracao|