Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
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|ClinicalTrials.gov Identifier: NCT01471899|
Recruitment Status : Unknown
Verified September 2013 by EMS.
Recruitment status was: Not yet recruiting
First Posted : November 16, 2011
Last Update Posted : September 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Back Pain||Drug: Ketorolac Tromethamine Drug: Naproxen||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||September 2014|
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.
- Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS). [ Time Frame: 4 days ]
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 ]Adverse events will be collected and followed in order to evaluate safety and tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471899
|Contact: Felipe Pinho, MDfirstname.lastname@example.org|
|Principal Investigator:||Pérola Plaper, MD||Instituto do Coracao|