EUCTR2004-003619-22-GB
Active, not recruiting
Not Applicable
A placebo-controlled study to investigate the efficacy of a combination analgesic treatment compared to its individual components in primary dysmenorrhoea.
GlaxoSmithKline Consumer Healthcare0 sites320 target enrollmentJuly 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- primary dysmenorrhoea
- Sponsor
- GlaxoSmithKline Consumer Healthcare
- Enrollment
- 320
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 3 years after menarche.
- •Patient known, by questioning, to have an adequate response to OTC analgesics in the treatment of dysmenorrhoea symptoms.
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
Outcomes
Primary Outcomes
Not specified
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