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

• Sponsor: EMS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01471899
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Actual Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain	Drug: Ketorolac Tromethamine; Drug: Naproxen	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Apr 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Naproxen 2 tablets every 8 hours for 4 days.	Drug: Naproxen; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• EMS

Investigators

• Principal Investigator: Pérola Plaper, MD, Instituto do Coracao

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EMS
• ClinicalTrials.gov Identifier: NCT01471899
• Other Study ID Numbers: CTRGEMS0611
• First Posted: Nov 16, 2011
• Last Update Posted: Feb 24, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Back Pain; Ketorolac; Ketorolac Tromethamine; Naproxen

Study Results

No Results Posted as of Feb 24, 2021