Last updated: 03/16/2021 15:50:05

Paracetamol with caffeine to treat episodic tension type headache

GSK study ID
A2260597
See study documents
Clinicaltrials.gov ID
NCT01755702
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-31-03
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    San Francisco Clinical Research Center
    San Francisco, CA, United States, 94109-4841
    Status
    Terminated/Withdrawn
    Contact us
    Location
    Michigan Head, Pain & Neurological Institute
    Ann Arbor, MI, United States, 48104
    Status
    Terminated/Withdrawn
    Contact us
    Location
    University Clinical Research, Inc.
    Pembroke Pines, FL, United States, 33024
    Status
    Terminated/Withdrawn
    Contact us
    Location
    Jefferson Headache Center
    Philadelphia, PA, United States, 19107
    Status
    Terminated/Withdrawn
    Contact us
    Location
    Biomedical Research Alliance of New York LLC
    Lake Success, NY, United States, 11042
    Status
    Terminated/Withdrawn
    Contact us
    Location
    International Research Service, Inc.
    Port Chester, NY, United States, 10573
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 11 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website