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

Study Overview
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Brief Summary
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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.

Official Title
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Placebo and Active Controlled, Double Dummy Phase III Study to Prove Efficacy of Aspirin (1000 mg Solid Dose) in Treatment of Acute Low Back Pain.

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 2<br> | Drug: Ibuprofen<br>* Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.<br>|
| Experimental: Arm 1<br> | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain, Acute low back pain