Comparison of a triple therapy versus monotherapy in patients with acute mechanical low back and/or cervical pai

Phase 3

• Conditions: Acute mechanical low back and/or cervical pain.; Dorsalgia, Cervicalgia, low back pain; M54, M54.2

• Registration Number: IRCT138807012498N1
• Lead Sponsor: Ache Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 714

Inclusion Criteria

Inclusion criteria

-Male or female subjects, 18 to 65 years of age
-Written informed consent
-Having acute mechanical lower back and/or cervical pain
-VAS score minimum of 50 mm at time of entry into study.

Exclusion criteria

-Subject is pregnant or lactating woman , or a woman of childbearing potential not using an acceptable method of contraception
-Medical history or physical examination results that suggest the pain, symptoms or signs are caused by a serious medical condition (e.g., fever in the last days, diabetes, cancer, rheumatic diseases, cardiac, liver, renal diseases)
-History of active peptic ulcer or gastrointestinal (GI) bleeding, history of gastric pain with NSAIDs,
-Known allergies, hypersensitivity, or intolerance to any drugs used in the study
-Known or suspected history of alcohol or drug abuse
-History of epilepsy or recurrent seizures
-Creatinine > 1.3 mg/dl

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)- pain. Timepoint: 3rd day of tretament. Method of measurement: Pain VAS scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluation. Timepoint: first visit and last visit (10 days). Method of measurement: SF-36 (Medical Otcomes Study 36 – Item Short-Form Health Survey).