Dysmenorrhoea Efficacy Study: fixed dose combination tablets of ibuprofen and acetaminophen for primary dysmenorrhoea
| ISRCTN | ISRCTN42521357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42521357 |
| EudraCT/CTIS number | 2008-006762-29 |
| Secondary identifying numbers | NL0804 |
- Submission date
- 07/10/2009
- Registration date
- 20/10/2009
- Last edited
- 30/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ronald Eccles
Scientific
Scientific
Common Cold Centre and Healthcare Clinical Trials Unit
Cardiff School of Biosciences
Museum Avenue
Cardiff University
Cardiff
CF10 3AX
United Kingdom
| Phone | +44 (0)2920 874 102 |
|---|---|
| eccles@cardiff.ac.uk |
Study information
| Study design | Double-blind randomised crossover single dose single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | Dysmenorrhoea Efficacy Study |
| Study objectives | 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(s) | South East Wales Ethics Committee panel B approved on the 14 January 2009 (ref: 09/WSE02/7) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 02/01/2009 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 85 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/01/2009 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Common Cold Centre and Healthcare Clinical Trials Unit
Cardiff
CF10 3AX
United Kingdom
CF10 3AX
United Kingdom
Sponsor information
Reckitt Benckiser Healthcare (UK)
Industry
Industry
c/o A Holbrook
Dansom Lane
Hull
HU8 7DS
United Kingdom
| Website | http://www.reckittbenckiser.com/home |
|---|---|
"ROR" |
https://ror.org/01g87hr29 |
Funders
Funder type
Industry
Reckitt Benckiser Healthcare (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
