Contact information
Type
Scientific
Primary contact
Prof Ronald Eccles
ORCID ID
Contact details
Common Cold Centre and Healthcare Clinical Trials Unit
Cardiff School of Biosciences
Museum Avenue
Cardiff University
Cardiff
CF10 3AX
United Kingdom
+44 (0)2920 874 102
eccles@cardiff.ac.uk
Additional identifiers
EudraCT number
2008-006762-29
ClinicalTrials.gov number
Protocol/serial number
NL0804
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary dysmenorrhoea
Intervention
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
Drug
Phase
Phase II/III
Drug names
Ibuprofen, acetaminophen
Primary outcome measure
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
02/01/2009
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Female
Target number of participants
85
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, sedativehypnotics 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
02/01/2009
Recruitment end date
30/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Common Cold Centre and Healthcare Clinical Trials Unit
Cardiff
CF10 3AX
United Kingdom
Sponsor information
Organisation
Reckitt Benckiser Healthcare (UK)
Sponsor details
c/o A Holbrook
Dansom Lane
Hull
HU8 7DS
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Reckitt Benckiser Healthcare (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20942614
Publication citations
-
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.