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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
338
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.
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.
Unnamed facility
Bad Lippspringe, Germany
Unnamed facility
Beckum, Germany
Unnamed facility
Einbeck, Germany
Unnamed facility
Hamburg, Germany
Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
Time frame: 48 hours
Total pain relief 6, 72, 96 and 120 hours after first dosing
Time frame: 6, 72, 96 and 120 hours
Pain intensity relief over initial 6 hours
Time frame: 6 hours
Pain intensity difference after 48, 72, 96 and 120 hours after first dosing
Time frame: 48, 72, 96 and 120 hours
Overall efficacy after 48, 72, 96 and 120 hours after first dosing
Time frame: 48, 72, 96 and 120 hours
Total dose used over 5 days
Time frame: 5 days
Time till use of rescue medication
Time frame: 5 days
Safety - assessment of adverse events
Time frame: 5 days
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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.
Unnamed facility
Hamburg, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Künzing, Germany
Unnamed facility
Straßkirchen, Germany
...and 3 more locations