Dysmenorrhoea Efficacy Study: fixed dose combination tablets of ibuprofen and acetaminophen for primary dysmenorrhoea | Not Recruiting
Dysmenorrhoea Efficacy Study: fixed dose combination tablets of ibuprofen and acetaminophen for primary dysmenorrhoea
Dysmenorrhoea Efficacy Study
Trial Source

Health Conditions
  • Primary dysmenorrhoea
Not Recruiting
Recruitment Status
ISRCTN42521357
Primary Trial ID Number
Summary
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
South East Wales Ethics Committee panel B approved on the 14 January 2009 (ref: 09/WSE02/7)
Publications
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20942614
Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
85
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 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
Interventions
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.
Design Details
Sorry, this information is not available
Study Design
Double-blind randomised crossover single dose single centre study
Results Reporting
Sorry, this information is not available
Acronym
Dysmenorrhoea Efficacy Study
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
Secondary Trial Identifying Number
NL0804
Website
Sorry, this information is not available
Study Funded By
Reckitt Benckiser Healthcare (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Reckitt Benckiser Healthcare (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

02 Jan 2009

Recruitment End Date

30 Jun 2009

Trial End Date

30 Jun 2009

Date added to Registry

20 Oct 2009

Last Updated

30 Mar 2011