Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain

December 8, 2009 updated by: Bayer

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.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
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.
Experimental: Arm 1
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.
Placebo Comparator: Arm 3
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Total pain relief 6, 72, 96 and 120 hours after first dosing
Time Frame: 6, 72, 96 and 120 hours
6, 72, 96 and 120 hours
Pain intensity relief over initial 6 hours
Time Frame: 6 hours
6 hours
Pain intensity difference after 48, 72, 96 and 120 hours after first dosing
Time Frame: 48, 72, 96 and 120 hours
48, 72, 96 and 120 hours
Overall efficacy after 48, 72, 96 and 120 hours after first dosing
Time Frame: 48, 72, 96 and 120 hours
48, 72, 96 and 120 hours
Total dose used over 5 days
Time Frame: 5 days
5 days
Time till use of rescue medication
Time Frame: 5 days
5 days
Safety - assessment of adverse events
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion

December 7, 2022

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2009

Last Update Submitted That Met QC Criteria

December 8, 2009

Last Verified

December 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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