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

Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471899

Enrollment

Registered

2011-11-16

Start date

2013-03-31

Completion date

2014-04-30

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

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.

Interventions

DRUGKetorolac Tromethamine

10 drops each 8 hours for 4 days.

DRUGNaproxen

2 tablets every 8 hours for 4 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026