Primary Dysmenorrhoea MedDRA version: 9.1 Level: LLT Classification code 10036689 Term: Primary dysmenorrhoea
Conditions
Interventions
Product Name: Ibuprofen 200mg and acetaminophen 500mg fixed dose combination tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687271
Concentration unit: mg milligram(s)
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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. | — |
Countries
United Kingdom
Outcome results
None listed