Oral treatment to evaluate the analgesic efficacy and safety of paracetamol / ibuprofen 500/200 mg compared with 500 mg paracetamol alone, ibuprofen 200 mg alone and placebo in patients with primary dysmenorrhea
- Conditions
- MODERATE TO SEVERE PAIN FOLLOWING DYSMENORRHOEATherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2015-002446-31-ES
- Lead Sponsor
- ABORATORIOS FARMALIDER S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1) Able to understand and sign the informed consent before participating in the study and willing to comply with all procedures and scheduled visits and to collect the information required by the protocol.
2) Women aged ? 18 years .
3) Primary dysmenorrhea with moderate to severe pain reaching a highest score of 40 mm Visual Analog Scale (VAS > 40 mm )
4) At least 4 painful menstrual cycles in the past six months , which have required pain medication .
5 ) regular menstrual cycles (28 ± 7 days).
6) Good general condition ( in the investigator's opinion), no clinically significant changes in clinical history, physical examination or laboratory tests .
7) Commit to use , in the investigator , a reliable method of contraception mind and be willing to continue that birth control throughout the study .
8) You agree not to take painkillers except for the protocol defined as rescue medication during the treatment period , until past 72 hours after administration of the first dose of study medication in each of the four study periods .
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 184
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) History of allergy or hypersensitivity to the study medication, rescue medication or other nonsteroidal antiinflammatory drugs (NSAIDs), paracetamol or aspirin, or any of its excipients.
2) History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema.
3) a history of peptic ulcer, gastrointestinal disorders NSAIDs, gastrointestinal bleeding or other active bleeding.
4) renal failure, liver or moderate to severe heart.
5) bleeding diathesis and other coagulation disorders.
6) uncontrolled epilepsy.
7) Crohn's disease or ulcerative colitis.
8) medical history of infection with Human Immunodeficiency Virus (HIV) or any serious immunocompromised state.
9) History of any type of malignancy during the five years prior to entry into this study.
10) history of drug dependence or alcohol abuse. For the purposes of the study, alcohol dependence is defined as follows: average weekly consumption> 21 units (men) and> 14 units (women), or average daily consumption> 3 units (men) and> 2 units (women ) (One unit corresponds to approx. 125 ml of wine, 200 ml of beer, 25 ml of spirits).
11) patients unable to abstain from alcohol, psychotropic drugs or sedatives (eg benzodiazepines) or other banned drugs as related below for 48 hours or 5 half-lives (whichever is longer) before the start of surgery and for 24 hours after administration of study medication. The prohibited drugs are: different analgesics study medication, anticoagulants, thrombolytics and antiplatelet agents, corticosteroids, MAO inhibitors, anticonvulsants, antipsychotics, inhibitors of serotonin reuptake and tricyclic antidepressants, lithium, methotrexate, sulfonamides.
12) Patients who have received an analgesic, anti-inflammatory, antispasmodic or other treatment for dysmenorrhea within 6 hours before taking the study medication
13) who received an experimental drug or used an experimental medical device within 30 days prior to screening.
14) pregnant or lactating women.
15) History of any disease or condition that, at the discretion of the investigator, would constitute a risk to the patient or alter the results of the study (eg patients with acute pain from any other source or location).
16) They may not meet the requirements of the study or in the investigator's opinion should not participate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to evaluate the analgesic efficacy of fixed-dose combination of ibuprofen and acetaminophen , oral administration , compared to the individual components and placebo in patients with moderate to severe primary dysmenorrhea .;Secondary Objective: The secondary objective the safety and tolerability of all preparations will be evaluated.;Primary end point(s): The primary endpoint will be the reduction of pain at 6 h of initiation of treatment , measured in terms of pain intensity difference (PID ) at each point of observation the first 6 hours ( PID0-6h ) and pain relief Total ( TOTPAR0-6h ) until 6 hours post - dose as the VAS score ( 0-100).;Timepoint(s) of evaluation of this end point: 6 hours
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 6 hours;Secondary end point(s): ?TOTPAR0-12, TOTPAR0-24h, SPID0-6h, SPID0-12h, SPID0-24h<br>? rate of use of rescue medication ,<br>? time to meaningful relief ,<br>? pain relief at each point of time, total pain relief at 6 ,<br>? patient global assessment