Low Back PainPhase 3NCT01028079
Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain
A Phase 3 study testing Acetylsalicylic Acid (Aspirin, BAYE4465) and Ibuprofen in people with Low Back Pain, run by Bayer at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE4465) and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Nov 2005to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Germany10 sites
Study site
Bad Lippspringe, 33175
Study site
Beckum, 59269
Study site
Einbeck, 37574
Study site
Hamburg, 20148
Study site
Hamburg, 20459
Study site
Hamburg, 21031
Study site
Hamburg, 22177
Study site
Hanover, 30519
Study site
Künzing, 94550
Study site
Straßkirchen, 94342
United Kingdom3 sites
Study site
Fowey, PL23 1DT
Study site
Saltash, PL12 6DL
Study site
Sheffield, S3 9DA
About this study
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.
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.
- Conditions
- Low Back Pain
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE4465), Ibuprofen, Placebo
- Keywords
- Back Pain, Acute low back pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Active comparator | Not described Receives: Drug: Ibuprofen |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
Measured: 48 hours
Secondary outcomes (7)
Total pain relief 6, 72, 96 and 120 hours after first dosing
Measured: 6, 72, 96 and 120 hours
Pain intensity relief over initial 6 hours
Measured: 6 hours
Pain intensity difference after 48, 72, 96 and 120 hours after first dosing
Measured: 48, 72, 96 and 120 hours
Overall efficacy after 48, 72, 96 and 120 hours after first dosing
Measured: 48, 72, 96 and 120 hours
Total dose used over 5 days
Measured: 5 days
Time till use of rescue medication
Measured: 5 days
Safety - assessment of adverse events
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028079
- Sponsor's protocol ID
- 11818
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01028079
- Acronym / sponsor ID
- 11818
- Conditions
- Low Back Pain
- Keywords
- Back Pain, Acute low back pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Active comparator | Drug: Ibuprofen |
| Arm 3 | Placebo comparator | Drug: Placebo |
| Arm 1 | Experimental | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Arm 1 |
| IbuprofenIbuprofen 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. | Drug | Arm 2 |
| PlaceboPlacebo (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. | Drug | Arm 3 |
Primary outcome
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
7 secondary outcomes
Total pain relief 6, 72, 96 and 120 hours after first dosing
Time frame: 6, 72, 96 and 120 hours
Pain intensity relief over initial 6 hours
Time frame: 6 hours
Pain intensity difference after 48, 72, 96 and 120 hours after first dosing
Time frame: 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
Total dose used over 5 days
Time frame: 5 days
Time till use of rescue medication
Time frame: 5 days
Safety - assessment of adverse events
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic Acid (Aspirin, BAYE4465) and Ibuprofen in people with Low Back Pain, run by Bayer at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.