Trial Condition(s):
Low Back Pain
Placebo and active controlled, double dummy study to prove efficacy of Aspirin in treatment of acute low back pain
Bayer Identifier:
11818
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Bad Lippspringe, Germany, 33175 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beckum, Germany, 59269 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Einbeck, Germany, 37574 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20459 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Künzing, Germany, 94550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fowey, United Kingdom, PL23 1DT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sheffield, United Kingdom, S3 9DA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20148 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 21031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22177 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30519 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Straßkirchen, Germany, 94342 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saltash, United Kingdom, PL12 6DL | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosingTimeframe: 48 hours
Secondary Outcome
- Total pain relief 6, 72, 96 and 120 hours after first dosingTimeframe: 6, 72, 96 and 120 hours
- Pain intensity relief over initial 6 hoursTimeframe: 6 hours
- Pain intensity difference after 48, 72, 96 and 120 hours after first dosingTimeframe: 48, 72, 96 and 120 hours
- Overall efficacy after 48, 72, 96 and 120 hours after first dosingTimeframe: 48, 72, 96 and 120 hours
- Total dose used over 5 daysTimeframe: 5 days
- Time till use of rescue medicationTimeframe: 5 days
- Safety - assessment of adverse eventsTimeframe: 5 days
Additional Information
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