NCT01028079

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P50-P75 for phase_3 low-back-pain

Timeline
Completed

Started Nov 2005

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

First QC Date

December 8, 2009

Last Update Submit

December 8, 2009

Conditions

Low Back Pain

Keywords

Back PainAcute low back pain

Outcome Measures

Primary Outcomes (1)

  • Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing

    48 hours

Secondary Outcomes (7)

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

    6, 72, 96 and 120 hours

  • Pain intensity relief over initial 6 hours

    6 hours

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

    48, 72, 96 and 120 hours

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

    48, 72, 96 and 120 hours

  • Total dose used over 5 days

    5 days

  • +2 more secondary outcomes

Study Arms (3)

Arm 2

ACTIVE COMPARATOR
Drug: Ibuprofen

Arm 3

PLACEBO COMPARATOR
Drug: Placebo

Arm 1

EXPERIMENTAL
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Interventions

Acetylsalicylic Acid (Aspirin, BAYE4465)DRUG

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.

Arm 1
IbuprofenDRUG

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.

Arm 2
PlaceboDRUG

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.

Arm 3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Bad Lippspringe, 33175, Germany

Location

Unknown Facility

Beckum, 59269, Germany

Location

Unknown Facility

Einbeck, 37574, Germany

Location

Unknown Facility

Hamburg, 20148, Germany

Location

Unknown Facility

Hamburg, 20459, Germany

Location

Unknown Facility

Hamburg, 21031, Germany

Location

Unknown Facility

Hamburg, 22177, Germany

Location

Unknown Facility

Hanover, 30519, Germany

Location

Unknown Facility

Künzing, 94550, Germany

Location

Unknown Facility

Straßkirchen, 94342, Germany

Location

Unknown Facility

Fowey, PL23 1DT, United Kingdom

Location

Unknown Facility

Saltash, PL12 6DL, United Kingdom

Location

Unknown Facility

Sheffield, S3 9DA, United Kingdom

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

AspirinIbuprofen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

November 1, 2005

Study Completion

December 1, 2006

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations

GB(3)DE(10)