Low Back Pain
Conditions
Keywords
Back Pain, Acute low back pain
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.
Interventions
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.
DRUGIbuprofen
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.
DRUGPlacebo
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.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 pain relief 6, 72, 96 and 120 hours after first dosing | 6, 72, 96 and 120 hours |
| Time till use of rescue medication | 5 days |
| Safety - assessment of adverse events | 5 days |
| Total dose used over 5 days | 5 days |
Countries
Germany, United Kingdom
Outcome results
None listed