A placebo-controlled study to investigate the efficacy of a combination analgesic treatment compared to its individual components in primary dysmenorrhoea.

• Conditions: primary dysmenorrhoea; MedDRA version: 7.1Classification code 10013935

• Registration Number: EUCTR2004-003619-22-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-20
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 320

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.
•Otherwise good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
•Patients of childbearing potential must be practicing, in the opinion of the investigator, a reliable method of contraception and must be willing to continue on their method of contraception throughout the study
•Patient should understand and is willing, able and likely to fully comply with all study procedures and restrictions
•Patient gives voluntary 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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified