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:

NCT01028079

EudraCT Number:

Not Available

Study Completed

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
338
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Bad Lippspringe, Germany, 33175

Status
Completed
 
Locations

Investigative Site

Beckum, Germany, 59269

Status
Completed
 
Locations

Investigative Site

Einbeck, Germany, 37574

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20459

Status
Completed
 
Locations

Investigative Site

Künzing, Germany, 94550

Status
Completed
 
Locations

Investigative Site

Fowey, United Kingdom, PL23 1DT

Status
Completed
 
Locations

Investigative Site

Sheffield, United Kingdom, S3 9DA

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20148

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 21031

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22177

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30519

Status
Completed
 
Locations

Investigative Site

Straßkirchen, Germany, 94342

Status
Completed
 
Locations

Investigative Site

Saltash, United Kingdom, PL12 6DL

Status
Completed
 

Trial Design