Clinical trial NCT01028079: Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Back Pain
Acute low back pain
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
timeFrame: 48 hours
Secondary outcomes:
measure: Total pain relief 6, 72, 96 and 120 hours after first dosing
timeFrame: 6, 72, 96 and 120 hours
measure: Pain intensity relief over initial 6 hours
timeFrame: 6 hours
measure: Pain intensity difference after 48, 72, 96 and 120 hours after first dosing
timeFrame: 48, 72, 96 and 120 hours
measure: Overall efficacy after 48, 72, 96 and 120 hours after first dosing
timeFrame: 48, 72, 96 and 120 hours
measure: Total dose used over 5 days
timeFrame: 5 days
measure: Time till use of rescue medication
timeFrame: 5 days
measure: Safety - assessment of adverse events
timeFrame: 5 days
Other outcomes:
Locations:
city: Bad Lippspringe
country: Germany
city: Beckum
country: Germany
city: Einbeck
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Künzing
country: Germany
city: Straßkirchen
country: Germany
city: Fowey
country: United Kingdom
city: Saltash
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: