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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Acetylsalicylic Acid (Aspirin, BAYE4465)

Ibuprofen

Placebo

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Back Pain, Acute low back pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm 2

Arm 3

Arm 1

Arm Description

Outcomes

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

Secondary Outcome Measures

Total pain relief 6, 72, 96 and 120 hours after first dosing

Pain intensity relief over initial 6 hours

Pain intensity difference after 48, 72, 96 and 120 hours after first dosing

Overall efficacy after 48, 72, 96 and 120 hours after first dosing

Total dose used over 5 days

Time till use of rescue medication

Safety - assessment of adverse events

Full Information

NCT ID

NCT01028079

First Posted

December 8, 2009

Last Updated

December 8, 2009

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01028079

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Back Pain, Acute low back pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

338 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Placebo Comparator

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Total pain relief 6, 72, 96 and 120 hours after first dosing

Time Frame

6, 72, 96 and 120 hours

Title

Pain intensity relief over initial 6 hours

Time Frame

6 hours

Title

Pain intensity difference after 48, 72, 96 and 120 hours after first dosing

Time Frame

48, 72, 96 and 120 hours

Title

Overall efficacy after 48, 72, 96 and 120 hours after first dosing

Time Frame

48, 72, 96 and 120 hours

Title

Total dose used over 5 days

Time Frame

5 days

Title

Time till use of rescue medication

Time Frame

5 days

Title

Safety - assessment of adverse events

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Bad Lippspringe

ZIP/Postal Code

33175

Country

Germany

City

Beckum

ZIP/Postal Code

59269

Country

Germany

City

Einbeck

ZIP/Postal Code

37574

Country

Germany

City

Hamburg

ZIP/Postal Code

20148

Country

Germany

City

Hamburg

ZIP/Postal Code

20459

Country

Germany

City

Hamburg

ZIP/Postal Code

21031

Country

Germany

City

Hamburg

ZIP/Postal Code

22177

Country

Germany

City

Hannover

ZIP/Postal Code

30519

Country

Germany

City

Künzing

ZIP/Postal Code

94550

Country

Germany

City

Straßkirchen

ZIP/Postal Code

94342

Country

Germany

City

Fowey

ZIP/Postal Code

PL23 1DT

Country

United Kingdom

City

Saltash

ZIP/Postal Code

PL12 6DL

Country

United Kingdom

City

Sheffield

ZIP/Postal Code

S3 9DA

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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