Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Ibuprofen; Drug: Placebo; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

• Registration Number: NCT01028079
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the study medication) by comparing it to placebo (the control group without active substance) or 400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of back pain. The study is designed to develop a treatment method against back pain which will have more advantages for patients than the methods that are currently available.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study Completion: 2006-12
• Status Verified: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Last Update Submitted: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Posted: 2009-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Ambulatory male or female, 18 to 70 years of age
• Body mass index ranging in-between 18 and 30 kg/m²
• Normal blood pressure
• Patients suffering from low back pain
• Low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain

Exclusion Criteria

• Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal Anti-inflammatory drugs
• Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
• Pregnancy or lactation period
• Abuse of alcohol or addictive substances

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Ibuprofen	-
Arm 3	Placebo	-
Arm 1	Acetylsalicylic Acid (Aspirin, BAYE4465)	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing	48 hours

Secondary Outcome Measures

Name	Time	Method
Total pain relief 6, 72, 96 and 120 hours after first dosing	6, 72, 96 and 120 hours
Pain intensity relief over initial 6 hours	6 hours
Pain intensity difference after 48, 72, 96 and 120 hours after first dosing	48, 72, 96 and 120 hours
Overall efficacy after 48, 72, 96 and 120 hours after first dosing	48, 72, 96 and 120 hours
Total dose used over 5 days	5 days
Time till use of rescue medication	5 days
Safety - assessment of adverse events	5 days