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

• Status: Completed
• Trial end date: 2014-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Ketorolac; Ketorolac Tromethamine; Naproxen

Criteria

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