Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Recruitment status was Not yet recruiting
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.
|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
|Contact: Felipe Pinho, MDemail@example.com|
|Principal Investigator:||Pérola Plaper, MD||Instituto do Coracao|