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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01028079
First received: December 8, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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.


Condition Intervention Phase
Low Back Pain
 Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Drug: Ibuprofen
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total pain relief 6, 72, 96 and 120 hours after first dosing [ Time Frame: 6, 72, 96 and 120 hours ] [ Designated as safety issue: No ]
  • Pain intensity relief over initial 6 hours [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Pain intensity difference after 48, 72, 96 and 120 hours after first dosing [ Time Frame: 48, 72, 96 and 120 hours ] [ Designated as safety issue: No ]
  • Overall efficacy after 48, 72, 96 and 120 hours after first dosing [ Time Frame: 48, 72, 96 and 120 hours ] [ Designated as safety issue: No ]
  • Total dose used over 5 days [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Time till use of rescue medication [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Safety - assessment of adverse events [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 338
Study Start Date: November 2005
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: Arm 2 Drug: Ibuprofen
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.
Placebo Comparator: Arm 3 Drug: Placebo
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.
Experimental: Arm 1 Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028079

Locations
Germany
Bad Lippspringe, Germany, 33175
Beckum, Germany, 59269
Einbeck, Germany, 37574
Hamburg, Germany, 22177
Hamburg, Germany, 21031
Hamburg, Germany, 20459
Hamburg, Germany, 20148
Hannover, Germany, 30519
Künzing, Germany, 94550
Straßkirchen, Germany, 94342
United Kingdom
Fowey, United Kingdom, PL23 1DT
Saltash, United Kingdom, PL12 6DL
Sheffield, United Kingdom, S3 9DA
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT01028079     History of Changes
Other Study ID Numbers: 11818
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Scotland: Scottish Executive Health Department
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Back Pain
Acute low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aspirin
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013