E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036689 |
E.1.2 | Term | Primary dysmenorrhoea |
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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 |
The primary objective of the study is to assess the efficacy of fixed dose combination tablets of 200 mg ibuprofen plus 500 mg acetaminophen, administered as one or two tablets (two tablets equivalent to 400 mg ibuprofen plus 1,000 mg acetaminophen) in comparison to placebo among patients experiencing moderate to severe pain due to primary dysmenorrhoea, in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject’s overall assessment of the study medication in a home setting. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective will be to evaluate the tolerability (adverse event profile) of the fixed dose combination tablets of 200 mg ibuprofen plus 500 mg acetaminophen administered as one or two tablets (two tablets equivalent to 400 mg ibuprofen plus 1,000 mg acetaminophen) in comparison to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Age: ≥18 2) Sex: Female 3) Primary diagnosis: Primary Dysmenorrhoea, with moderat-severe cramping pain in at least 4 of the previous 6 months. 4) Status: These subjects will be members of the public who respond to any study specific advertising, or have indicated to staff that they wish to participate in a dysmenorrhoea trial. 5) Subjects who have given written informed consent
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E.4 | Principal exclusion criteria |
1) A history of significant disease deemed by the investigator to render the subject unsuitable for inclusion. 2) Any significant ongoing painful condition other than that associated with primary dysmenorrhoea. 3) Any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication. 4) A history of peptic ulcer, duodenal ulcer, gastrointestinal bleeding. 5) A history of frequent dyspepsia, heartburn or indigestion. 6) A history of psychotic illness, attempted suicide, or neurosis. 7) A positive history of drug or alcohol abuse within the past year. 8) Those taking any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative –hypnotics taken within fives times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) are permitted if the subject has been on a stable dose for at least four weeks prior to Visit 1 (screening) and remain on this dose throughout the study. 9) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). 10) A history of inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any previous history of allergy or known intolerance to any of the drugs or formulation constituents which, in the Investigator’s opinion, might preclude use of an NSAID, including aspirin sensitive asthma or a previous allergic response to a NSAID, including bronchospasm, urticaria, angioedema and rhinitis. 11) Those previously randomised into this study 12) Subjects who have received any analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea within 6 hours of taking the study medication. 13) Those who have participated in a clinical trial in the previous 30 days weeks are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial. 14) Those suffering with anaemia – (blood test at screening visit) Those unable, in the opinion of the investigator, to comply fully with the study requirements
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary analgesic efficacy endpoint will be the total pain relief over 6 hours post-dose (TOTPAR0-6h), with pain relief (PR) rated on a 5-point scale: 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, 4 = complete pain relief. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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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The end of the study is defined as the last visit of the last subject undergoing the study.
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |