DYSMENORRHOEA
Conditions
Interventions
Product Name: Ibuprofen/paracetamol 200/500 mg granules
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concen
Sponsors
Laboratorios Farmalíder S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Female subjects able to understand and sign the informed consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and the right to deny their collaboration at any time throughout the study 2) Females aged > 18 years. 3) Primary Dysmenorrhoea with moderate or severe pain, with pain score higher or equal than 50 mm in the Visual Assessment Scale (VAS = 50 mm) 4) At least four menstrual painful periods in the last six months that has needed analgesic treatment. 5) Regular menstrual cycle (28 ± 7 days). 6) Clinical History, physical examination and laboratory results without clinically relevant alterations. 7) Women who commit to use a reliable method of contraception, in opinion of the investigators, throughout the study. 8) Who agree not to take other analgesic drug different from the study drugs or the rescue medication during the study (until 72 hours after the first study drug administration). 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 480 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of allergy or hypersensitivity to the study drugs, including rescue medication or any other NSAID or their excipients. 2) History of bronchial asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema. 3) History of peptic ulcer, NSAID gastrointestinal adverse reactions, gastrointestinal bleeding or other active bleeding disorders. 4) Moderate or severe hepatic, renal or cardiac active diseases. 5) Active disorders of blood coagulation. 6) Uncontrolled Epilepsy. 7) Ulcerative colitis or Crohn´s disease. 8) History of drug or alcohol abuse or dependency. Alcohol dependency must be considered as a weekly alcohol consumption of more than 14 units or a daily consumption of more than 2 units (One unit corresponds to 125 mL wine, 200 mL beer or 25 mL spirits). 9) Patients unable to abstain of alcohol, psychotropic or sedative drugs (i.e. benzodiazepines) or other forbidden medicines (see below) at least 48 hours or five elimination half-lives before or 24 h alter drug study administration. Forbidden drugs are NSAIDs other than those of the study, anticoagulants, thrombolytics and platelet antiaggregants, corticoids, MAO inhibitors, antipsychotics, antiepileptic drugs, SSRI, tricyclic antidepressants, sulfamides, methotrexate and lithium. 10) Patients who have taken any analgesic, anti-inflammatory, antispasmodic or other treatment for dysmenorrhoea within six hours before study drug administration. 11) Participants in any clinical trial (with experimental drugs or experimental medical devices) within the 30 days before the screening process. 12) Pregnant or lactating women. 13) History of any medical condition which in the opinion of investigators, may constitute a risk for the patient, or modify the study results. 14) Subjects who cannot meet the requirements of the study or that in the opinion of the researchers cannot participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective will be the evaluation of the analgesic effect of the fixed dose combination of Ibuprofen 200 mg and Paracetamol 500 mg for oral administration compared with Paracetamol 500 mg and Ibuprofen 200 mg alone and placebo in patients with dysmenorrhoea with moderate to severe pain.;Secondary Objective: Evaluation of safety and tolerability of the Ibuprofen-Paracetamol formulation and the monocomponents will be the secondary objective of the study.;Primary end point(s): Main Efficacy Variable: The study main variable will be the pain relief observed 6 hours after beginning of treatment, evaluated as Pain Intensity difference (PID) VAS measured (0-100 mm).;Timepoint(s) of evaluation of this end point: 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Variables: also will be analyzed: • Total Pain Relief (TOTPAR) at TOTPAR0-6h, TOTPAR0-12h, TOTPAR0-24h, and the Sum of Pain Intensity Difference (SPID) at SPID0-6h, SPID0-12h, SPID0-24h • Pain Relief at every time-point (hour) from 0 to 6 hours. • Frequency of rescue medication use. • Time to significant pain relief. • Rate of responding patients. • Patient global assessment. Safety Variables: Safety evaluation will include physical examination, including vital signs (BP, HR, BT), adverse events counting. Safety Follow-up visit will include results of laboratory test.;Timepoint(s) of evaluation of this end point: 12h, 24h, 1 month, 1month +1 week | — |
Countries
Spain
Contacts
Public ContactMiriam Bellido
Laboratorios Farmalíder S.A.
Outcome results
None listed