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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-11-11

Brief Summary

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The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

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Detailed Description

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* 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 analog scale.
* Adverse events evaluation.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Naproxen

Every 8 hours for 4 days.

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Every 8 hours for 4 days.

Ketorolac Tromethamine

Every 8 hours for 4 days

Group Type EXPERIMENTAL

Ketorolac Tromethamine

Intervention Type DRUG

Every 8 hours for 4 days.

Interventions

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Ketorolac Tromethamine

Every 8 hours for 4 days.

Intervention Type DRUG

Naproxen

Every 8 hours for 4 days.

Intervention Type DRUG

Eligibility Criteria

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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 Analog Scale 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No