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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
| |
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bad Lippspringe | 33175 | Germany | ||||
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|
| Ibuprofen | Drug | 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 | Drug | 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. |
|
| 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 |
| Time till use of rescue medication | 5 days |
| Safety - assessment of adverse events | 5 days |
| Beckum |
| 59269 |
| Germany |
| Einbeck | 37574 | Germany |
| Hamburg | 20148 | Germany |
| Hamburg | 20459 | Germany |
| Hamburg | 21031 | Germany |
| Hamburg | 22177 | Germany |
| Hanover | 30519 | Germany |
| Künzing | 94550 | Germany |
| Straßkirchen | 94342 | Germany |
| Fowey | PL23 1DT | United Kingdom |
| Saltash | PL12 6DL | United Kingdom |
| Sheffield | S3 9DA | United Kingdom |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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