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

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471886
• Other study ID #: CTREMS0611
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: November 11, 2013

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 analog scale.

• Adverse events evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 11, 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

Drug:
• Ketorolac Tromethamine
Every 8 hours for 4 days.
• Naproxen
Every 8 hours for 4 days.

Locations

Country	Name	City	State
Brazil	IOT - Instituto de Ortopedia e Traumatologia	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Plapler PG, Scheinberg MA, Ecclissato Cda C, Bocchi de Oliveira MF, Amazonas RB. Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain. Drug Des Devel Ther. 2016 Jun 17;10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS).	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;	4 days
Secondary	Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	day 4