Clinical trial NCT01755702: Paracetamol With Caffeine to Treat Episodic Tension Type Headache
Official title: A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Headache, Tension-Type
Keywords: caffeine
paracetamol
tension headache
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Time to First Perceptible Headache Relief
timeFrame: Baseline to 6 hours
Secondary outcomes:
measure: Headache Relief Scores
timeFrame: Baseline to 4 hours
measure: Total Pain Relief (TOTPAR)
timeFrame: Baseline to 4 hours
measure: Sum of Pain Intensity Difference (SPID)
timeFrame: Baseline to 4 hours
measure: Sum of TOTPAR and SPID (SPRID)
timeFrame: Baseline to 4 hours
measure: Time to Rescue Medication
timeFrame: Baseline to 6 hours post dose
measure: Number of Participants With Complete Headache Relief
timeFrame: Baseline to 2 hours
measure: Headache Severity
timeFrame: Baseline to 4 hours
measure: Patients Global Assessment in Response to Treatment
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Springfield
country: United States
facility: Springfield Neurology Associates
state: Massachusetts
city: Wellesley Hills
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Lake Success
country: United States
facility: Biomedical Research Alliance of New York LLC
state: New York
city: Mount Vernon
country: United States
facility: Elkind Headache Center
state: New York
city: Port Chester
country: United States
facility: International Research Service, Inc.
state: New York
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: