check_circleStudy Completed

Low Back Pain

Bayer Identifier:

11818

ClinicalTrials.gov Identifier:

NCT01028079

EudraCT Number:

Not Available

EU CT Number:

Not Available
Placebo and active controlled, double dummy study to prove efficacy of Aspirin in treatment of acute low back pain

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.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years


  • - 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
  • - 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
November 2005 - December 2006
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Bad Lippspringe, 33175, Germany
Completed
Beckum, 59269, Germany
Completed
Einbeck, 37574, Germany
Completed
Hamburg, 20459, Germany
Completed
Künzing, 94550, Germany
Completed
Fowey, PL23 1DT, United Kingdom
Completed
Sheffield, S3 9DA, United Kingdom
Completed
Hamburg, 20148, Germany
Completed
Hamburg, 21031, Germany
Completed
Hamburg, 22177, Germany
Completed
Hannover, 30519, Germany
Completed
Straßkirchen, 94342, Germany
Completed
Saltash, PL12 6DL, United Kingdom

Primary Outcome

  • Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
    date_rangeTime Frame:
    48 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Total pain relief 6, 72, 96 and 120 hours after first dosing
    date_rangeTime Frame:
    6, 72, 96 and 120 hours
    enhanced_encryption
    Safety Issue:
    No
  • Pain intensity relief over initial 6 hours
    date_rangeTime Frame:
    6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Pain intensity difference after 48, 72, 96 and 120 hours after first dosing
    date_rangeTime Frame:
    48, 72, 96 and 120 hours
    enhanced_encryption
    Safety Issue:
    No
  • Overall efficacy after 48, 72, 96 and 120 hours after first dosing
    date_rangeTime Frame:
    48, 72, 96 and 120 hours
    enhanced_encryption
    Safety Issue:
    No
  • Total dose used over 5 days
    date_rangeTime Frame:
    5 days
    enhanced_encryption
    Safety Issue:
    No
  • Time till use of rescue medication
    date_rangeTime Frame:
    5 days
    enhanced_encryption
    Safety Issue:
    No
  • Safety - assessment of adverse events
    date_rangeTime Frame:
    5 days
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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