Last updated: 03/16/2021 15:50:05
Paracetamol with caffeine to treat episodic tension type headache
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: A study to assess the efficacy of paracetamol taken in combination with caffeine for the treatment of episodic tension type headache
Trial description: This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Time to first perceptible headache relief
Timeframe: Baseline to 6 hours
Secondary outcomes:
Headache relief scores
Timeframe: Baseline to 4 hours
Total pain relief (TOTPAR)
Timeframe: Baseline to 4 hours
Sum of pain intensity difference (SPID)
Timeframe: Baseline to 4 hours
Sum of TOTPAR and SPID (SPRID)
Timeframe: Baseline to 4 hours
Time to rescue medication
Timeframe: Baseline to 6 hours post dose
Number of participants with complete headache relief
Timeframe: Baseline to 2 hours
Headache severity
Timeframe: Baseline to 4 hours
Patients Global Assessment in Response to Treatment
Timeframe: Baseline to 8 weeks
Interventions:
Drug: Placebo
Drug: Experimental paracetamol + caffeine formulation
Drug: ibuprofen marketed formulation
Drug: Paracetamol marketed formulation
Enrollment:
66
Observational study model:
Not applicable
Primary completion date:
2010-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Headache, Tension-Type
Product
paracetamol
Collaborators
Not applicable
Study date(s)
July 2009 to March 2010
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Diagnosis of episodic tension-type headache consistent with all of the following:
- 1) number of days with the condition is historically greater than or equal to two per month
- Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
- If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of episodic tension-type headache consistent with all of the following: 1) number of days with the condition is historically greater than or equal to two per month 2) onset of condition was greater than or equal to 12 months from Visit 1 3) age of onset was < 50 years 4) severity of headaches is historically at least moderate 5) duration of headaches is historically greater than or equal to four hours, if untreated 6) number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1 7) treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
Exclusion criteria:
- Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
- If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
Trial location(s)
Location
San Francisco Clinical Research Center
San Francisco, CA, United States, 94109-4841
Status
Terminated/Withdrawn
Location
Michigan Head, Pain & Neurological Institute
Ann Arbor, MI, United States, 48104
Status
Terminated/Withdrawn
Location
University Clinical Research, Inc.
Pembroke Pines, FL, United States, 33024
Status
Terminated/Withdrawn
Location
Jefferson Headache Center
Philadelphia, PA, United States, 19107
Status
Terminated/Withdrawn
Location
Biomedical Research Alliance of New York LLC
Lake Success, NY, United States, 11042
Status
Terminated/Withdrawn
Location
International Research Service, Inc.
Port Chester, NY, United States, 10573
Status
Terminated/Withdrawn
Location
PharmaSite Research, Inc.
Baltimore, MD, United States, 21208
Status
Terminated/Withdrawn
Location
Miami Research Associates
South Miami, FL, United States, 33143
Status
Terminated/Withdrawn
Location
Elkind Headache Center
Mount Vernon, NY, United States, 10550
Status
Terminated/Withdrawn
Location
MedVadis Research Corporation
Wellesley Hills, MA, United States, 02481
Status
Terminated/Withdrawn
Location
Springfield Neurology Associates
Springfield, MA, United States, 01104
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2010-31-03
Actual study completion date
2010-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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