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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028079
• Other study ID #: 11818
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2009
• Last updated: December 8, 2009
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health DepartmentGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing		48 hours	No
Secondary	Total pain relief 6, 72, 96 and 120 hours after first dosing		6, 72, 96 and 120 hours	No
Secondary	Pain intensity relief over initial 6 hours		6 hours	No
Secondary	Pain intensity difference after 48, 72, 96 and 120 hours after first dosing		48, 72, 96 and 120 hours	No
Secondary	Overall efficacy after 48, 72, 96 and 120 hours after first dosing		48, 72, 96 and 120 hours	No
Secondary	Total dose used over 5 days		5 days	No
Secondary	Time till use of rescue medication		5 days	No
Secondary	Safety - assessment of adverse events		5 days	Yes

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