E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of tension headache |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints in assessing efficacy will be: • Total Pain Relief (TOTPAR) to 30 minutes. TOTPAR = Σ(Rt x (timet - timet-1)), where Rt = pain relief score at time t, and timet = time in hours. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last subject, last visit.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |