Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Ronald Eccles


Contact details

Common Cold Centre and Healthcare Clinical Trials Unit
Cardiff School of Biosciences
Museum Avenue
Cardiff University
CF10 3AX
United Kingdom
+44 (0)2920 874 102

Additional identifiers

EudraCT number

2008-006762-29 number

Protocol/serial number


Study information

Scientific title

A double-blind, randomised crossover, single dose, single centre, study examining the analgesic efficacy and tolerability of fixed-dose combinations of ibuprofen 200 mg and acetaminophen 500 mg, ibuprofen 400 mg and acetaminophen 1,000 mg and placebo in primary dysmenorrhoea


Dysmenorrhoea Efficacy Study

Study hypothesis

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.

Ethics approval

South East Wales Ethics Committee panel B approved on the 14 January 2009 (ref: 09/WSE02/7)

Study design

Double-blind randomised crossover single dose single centre study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Primary dysmenorrhoea


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.

The treatments were single doses of the test medicine taken on three menstrual cycles if the pain was of sufficient intensity to need treatment. The duration of the follow-up was for up to five days after the last dose of treatment.

Intervention type



Phase II/III

Drug names

Ibuprofen, acetaminophen

Primary outcome measures

The primary analgesic efficacy endpoint will be the total pain relief over 6 hours post-dose

Secondary outcome measures

Total pain relief over 2 and 4 hours post-dose

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Female patients aged greater than or equal to 18 years
2. Primary diagnosis of primary dysmenorrhoea, with moderate-severe cramping pain in at least 4 of the previous 6 months
3. Responded to any study-specific advertising, or have indicated to staff that they wish to participate in a dysmenorrhoea trial
4. Have given written informed consent

Participant type


Age group




Target number of participants


Participant 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 non-steroidal anti-inflammatory drug [NSAID], including aspirin sensitive asthma or a previous allergic respresponse 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)
15. Those unable, in the opinion of the investigator, to comply fully with the study requirements

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Common Cold Centre and Healthcare Clinical Trials Unit
CF10 3AX
United Kingdom

Sponsor information


Reckitt Benckiser Healthcare (UK)

Sponsor details

c/o A Holbrook
Dansom Lane
United Kingdom

Sponsor type




Funder type


Funder name

Reckitt Benckiser Healthcare (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in

Publication citations

  1. Results

    Eccles R, Holbrook A, Jawad M, A double-blind, randomised, crossover study of two doses of a single-tablet combination of ibuprofen/paracetamol and placebo for primary dysmenorrhoea., Curr Med Res Opin, 2010, 26, 11, 2689-2699, doi: 10.1185/03007995.2010.525028.

Additional files

Editorial Notes