Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

Phase 3

Completed

• Conditions: Back Pain
• Interventions: Drug: Naproxen; Drug: Ketorolac Tromethamine

• Registration Number: NCT01471899
• Lead Sponsor: EMS

Brief 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.

Study Timeline

• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Study Start: 2013-03
• Primary Completion: 2013-12
• Study Completion: 2014-04-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Consent of the patient or legal guardian.
• Men or women aged between 18 and 65.
• Diagnosis of acute low back pain with moderate to severe pain (Visual Analogic score greater than 4 cm)

Exclusion Criteria

• fracture confirmed by X-ray
• Diagnosis of infection, fever,
• Pregnancy, lactation;
• Diagnosis of fibromyalgia;
• Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naproxen	Naproxen	2 tablets every 8 hours for 4 days.
Ketorolac Tromethamine	Ketorolac Tromethamine	10 drops every 8 hours for 4 days

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).	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; Considering: * VASvi: VAS in the first visit; * VASvf: VAS at the last visit;

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	day 4	Adverse events will be collected and followed in order to evaluate safety and tolerability