HeadachePhase 4NCT01464983
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
A Phase 4 study testing Acetylsalicylic acid (Aspirin, BAYE4465) and Ibuprofen in people with Headache and Tension-Type Headache, run by Bayer at 11 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Tension-Type Headache, Tension-Type Headache (Episodic)
- What is being tested?
- Acetylsalicylic acid (Aspirin, BAYE4465) and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,115 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- Jan 2004to Aug 2004
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory male or female, 18 to 65 years of age
- Normal blood pressure
- Patients suffering from episodic tension-type headache
- Headache lasting from 30 minutes to 7 days
- Headache had at least two of the following characteristics:
- Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.
- Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.
Who cannot join
- Other headaches, including migraine, that required medical treatment
- Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
- Mental illness, including depression
- Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
- Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
- Participating in any other clinical study or had done within the previous 4 weeks
- Had been previously enrolled in this study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Study site
Birmingham, West Midlands, B15 2SQ
Study site
Cardiff, South Glamorgan, CF14 5GJ
Study site
Chorley, Lancashire, PR7 1NY
Study site
Coventry, West Midlands, CV1 2TZ
Study site
Glasgow, Strathclyde, G81 2DR
Study site
Liverpool, Merseyside, L1 9AD
Study site
Liverpool, Merseyside, L22 0LG
Study site
Manchester, Greater Manchester, M15 6SX
Study site
Reading, Berkshire, RG2 7AG
Study site
Wigan, Lancashire, WN6 9EW
Study site
Wolverhampton, West Midlands, WV10 9RU
About this study
Official title: A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache
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.
- Being tested
- Acetylsalicylic acid (Aspirin, BAYE4465), Ibuprofen, Placebo
- Medical subject headings
- Headache, Tension-Type Headache, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid (Aspirin, BAYE4465)Drug
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
Acetylsalicylic acid (Aspirin, BAYE4465)Drug
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
IbuprofenDrug
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
IbuprofenDrug
Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
PlaceboDrug
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 2 | Experimental | Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 3 | Active comparator | Not described Receives: Drug: Ibuprofen |
| Arm 4 | Active comparator | Not described Receives: Drug: Ibuprofen |
| Arm 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
Measured: 2 hours post dose
Secondary outcomes (4)
Headache pain relief measured serially on a categorical scale
Measured: Until 4 hours post dose
Measuring the functional ability on conducting everydays activity on a 4 point categorical scale
Measured: 2 and 24 hours post dose
Global assessment of pain therapy
Measured: 24 hours post dose
Safety - assessment of adverse events
Measured: Up to 10 weeks after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startJan 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464983
- Sponsor's protocol ID
- 11220
- Status last verified
- Dec 2014
- First submitted
- 17 May 2011
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache
- ClinicalTrials.gov ID
- NCT01464983
- Acronym / sponsor ID
- 11220
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Aug 2004 (actual)
- First posted
- 4 Nov 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 2 | Experimental | Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 3 | Active comparator | Drug: Ibuprofen |
| Arm 4 | Active comparator | Drug: Ibuprofen |
| Arm 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ambulatory male or female, 18 to 65 years of age
- Normal blood pressure
- Patients suffering from episodic tension-type headache
- Headache lasting from 30 minutes to 7 days
- Headache had at least two of the following characteristics:
Key exclusion criteria (8 listed)
- Other headaches, including migraine, that required medical treatment
- Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
- Mental illness, including depression
- Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
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)Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen | Drug | Arm 1 |
| Acetylsalicylic acid (Aspirin, BAYE4465)Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen | Drug | Arm 2 |
| IbuprofenIbuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid | Drug | Arm 3 |
| IbuprofenIbuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid | Drug | Arm 4 |
| Placebo2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose | Drug | Arm 5 |
Primary outcome
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
Time frame: 2 hours post dose
4 secondary outcomes
Headache pain relief measured serially on a categorical scale
Time frame: Until 4 hours post dose
Measuring the functional ability on conducting everydays activity on a 4 point categorical scale
Time frame: 2 and 24 hours post dose
Global assessment of pain therapy
Time frame: 24 hours post dose
Safety - assessment of adverse events
Time frame: Up to 10 weeks after screening
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 25 Dec 2014.
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetylsalicylic acid (Aspirin, BAYE4465) and Ibuprofen in people with Headache and Tension-Type Headache, run by Bayer at 11 sites in United Kingdom.
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 7 inclusion and 8 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 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication (time frame: 2 hours post dose). 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 25 Dec 2014.