Treatment of tension headache
Conditions
Interventions
Product Name: Paracetamol-Caffeine 500/65mg Film-coated Tablets
Product Code: MFC50613
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Para
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects, aged 18-65 years inclusive, diagnosed with tension-type headache in accordance with the criteria established by the International Headache Society 2004(3). Subjects must experience between two and ten headaches of moderate or severe intensity per month and must gain at least some relief from OTC analgesics. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Disease a) Clinician diagnosed migraine headache, post-concussion headache or cluster headache within the last year. b) Menstrual headache (which in the opinion of the investigator the subject cannot differentiate from tension-type headache). c) In the opinion of the Investigator, significant head/neck injury or change in headache pattern during the previous 6 months. d) Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder (except headache) that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from study medication or procedures. e) Severe liver or kidney disease. f) Current or history of stomach ulcer or other stomach disorder. g) History of bronchospasm, rhinitis or urticaria associated with aspirin or Nonsteroidal Anti-inflammatory Drugs (NSAIDs). h) Asthma. 2) Medications a) Current use of prescription medication for headache. b) Current use of antipsychotic, antidepressant, muscle relaxant, sedative or antiepileptic medications. c) Continuous treatment with prescription doses of analgesics or NSAIDs. d) Use of analgesics on more than 10 days per month to treat headache. 3) Abuse Recent history (within one year) of alcohol abuse or other substance abuse. 4) Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study treatments or rescue medication (paracetamol, caffeine or ibuprofen) or any of their stated ingredients. 5) Pregnancy Women who are pregnant or who have a positive urine pregnancy test. 6) Breast-feeding Women who are breast–feeding. 7) Clinical Trials/Experimental Medication a) Participation in another clinical trial or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study. 8) Personel An employee of the sponsor or the study site or members of their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare total pain relief over 30 minutes (TOTPAR 0-30 minutes) for a rapidly absorbed paracetamol + caffeine (RAPC) tablet versus placebo and versus ibuprofen tablet. ; Secondary Objective: Other comparisons of pain relief, of headache resolution and of global evaluation between treatments will be made over the 4 hour study period. A comparison of adverse events (AEs) will also be made. ; Primary end point(s): The primary endpoints in assessing efficacy will be: • Total Pain Relief (TOTPAR) to 30 minutes. TOTPAR = S(Rt x (timet - timet-1)), where Rt = pain relief score at time t, and timet = time in hours. | — |
Countries
United Kingdom
Outcome results
None listed