primary dysmenorrhoea MedDRA version: 7.1 Classification code 10013935
Conditions
Interventions
Trade Name: Panadol Extra Tablets
Product Name: Panadol Extra Tablets
Product Code: Not applicable
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Paracetamol
Other descriptive name: acetamin
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female subjects aged 18 years upwards. Self-reported history of Grade 2 or 3 (Andersch and Milsom scoring system – Am J Obstet Gynecol 1982; 144:655-660) primary dysmenorrhoea. ? Grade 0 = menstruation is not painful, and daily activity is unaffected. OTC analgesics are not required. ? Grade 1 = menstruation is painful but seldom inhibits normal activity; OTC analgesics are seldom required; mild pain. ? Grade 2 = daily activity unaffected; OTC analgesics required and give sufficient relief so that absence from college or work is unusual; moderate pain ? Grade 3 = Activity clearly inhibited; poor effect of analgesics; vegetative symptoms (eg. headache, fatigue, nausea, backache); severe pain • At least 3 painful menstrual cycles during the previous 4 months which have required medication with OTC analgesics. • Duration of menstrual cycle within the range 21-35 days. Onset of dysmenorrhoea =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or lactating or attempting to become pregnant • Recent history (within the last 2 years) of analgesic, alcohol or other substance abuse. Abuse is defined as self-reported, diagnosed or treated • Have known or suspected intolerance or hypersensitivity to the study treatments (paracetamol or caffeine) or any of their stated ingredients or any related compounds • Have known or suspected intolerance or hypersensitivity to ibuprofen (rescue medication) • Medical history which renders patient unable to take study treatments or rescue medication ? Severe liver or kidney disease (paracetamol) ? Current or history of stomach ulcer or other stomach disorder (ibuprofen) ? Asthma (ibuprofen) • Clinical Study/Experimental Medication ? Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study ? Previous participation in this study • Personnel An employee of the sponsor or the study site. • Positive urine screen for drugs of abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : To compare the efficacy of a single dose of paracetamol and caffeine with a single dose of paracetamol alone for pain relief in patients with primary dysmenorrhoea symptoms. To compare the efficacy of a single dose of paracetamol and caffeine with a single dose of caffeine alone for pain relief in patients with primary dysmenorrhoea symptoms ;Secondary Objective: •To compare the efficacy of a single dose of paracetamol and caffeine with a single dose of paracetamol alone for abdominal cramping, backache and tiredness in patients with primary dysmenorrhoea symptoms. •To compare the efficacy of a single dose of paracetamol and caffeine with a single dose of caffeine alone for abdominal cramping, backache and tiredness in patients with primary dysmenorrhoea symptoms. •To compare the efficacy of a single dose of paracetamol and caffeine with a single dose of placebo for pain relief, abdominal cramping, backache and tiredness in patients with primary dysmenorrhoea symptoms. •To compare the efficacy of a single dose of paracetamol alone with a single dose of placebo for pain relief, abdominal cramping, backache and tiredness in patients with primary dysmenorrhoea symptoms. •To assess the safety (adverse events) of a single dose of Panadol Extra Tablets (1000 mg/130 mg), Panadol Tablets (1000 mg), caffeine tablet (130 mg) and placebo tablet. ;Primary end point(s): Primary endpoint: TOTPAR0-2 hours for pain relief. TOTPAR0-2 hours will be generated for each patient by summing the pain relief scores of none (0), a little (1), some (2), a lot (3) and complete (4) over the time points from 0 to 2 hours, weighting for the nominal time between time points. | — |
Countries
United Kingdom
Outcome results
None listed