check_circleStudy Completed
Headache, Tension-Type Headache, Tension-Type Headache (episodic)
Bayer Identifier:infoA unique number for a trial given by Bayer.
11220
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Placebo and active controlled, double dummy study to compare efficacy of Aspirin and Ibuprofen in treatment of episodic tension-type headache
Trial purpose
The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg Aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. The study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal info
1115The overall number of participants needed for a trial.
Trial Dates info
January 2004 - August 2004Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
YesA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Aspirin (Acetylsalicylic Acid, BAYE4465)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Birmingham, B15 2SQ, United Kingdom | |
Completed | Coventry, CV1 2TZ, United Kingdom | |
Completed | Chorley, PR7 1NY, United Kingdom | |
Completed | Liverpool, L22 0LG, United Kingdom | |
Completed | Liverpool, L1 9AD, United Kingdom | |
Completed | Reading, RG2 7AG, United Kingdom | |
Completed | Wolverhampton, WV10 9RU, United Kingdom | |
Completed | Wigan, WN6 9EW, United Kingdom | |
Completed | Cardiff, CF14 5GJ, United Kingdom | |
Completed | Glasgow, G20 OSP, United Kingdom | |
Completed | Glasgow, G20 OSP, United Kingdom | |
Completed | Manchester, M15 6SX, United Kingdom |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medicationdate_rangeTime Frame:2 hours post doseenhanced_encryptionnoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Headache pain relief measured serially on a categorical scaledate_rangeTime Frame:Until 4 hours post doseenhanced_encryptionnoSafety Issue:
- Measuring the functional ability on conducting everydays activity on a 4 point categorical scaledate_rangeTime Frame:2 and 24 hours post doseenhanced_encryptionnoSafety Issue:
- Global assessment of pain therapydate_rangeTime Frame:24 hours post doseenhanced_encryptionnoSafety Issue:
- Safety - assessment of adverse eventsdate_rangeTime Frame:Up to 10 weeks after screeningenhanced_encryptionyesSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Double Blind“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
5A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.