Hyoscine butylbromide co-administered with ibuprofen in dysmenorrhea
- Conditions
- Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]DysmenorrhoeaMedDRA version: 20.0Level: PTClassification code 10013935Term: DysmenorrhoeaSystem Organ Class: 10038604 - Reproductive system and breast disorders
- Registration Number
- EUCTR2019-004138-41-DE
- Lead Sponsor
- Sanofi-Aventis Groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
- Female of at least 18 (inclusive) and up to 47 years of age (inclusive), at Screening, with primary dysmenorrhea suffering from moderate to severe cramping pain in the last 4 months (abdominal pain intensity = 4 on 0-to-10 NRS) prior to Screening.
- Not pregnant or breastfeeding and who agrees not to become pregnant during the study.
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Any concurrent disease or condition that would make the subject unsuitable for participation in the clinical trial including any suspected or confirmed COVID-19 condition.
- Subject with known anemia or significant ongoing painful condition other than PD.
- Secondary dysmenorrhea (eg endometriosis, salpingitis, adhesion), as indicated by known medical history or by gynecological examination at Visit 1.
- Known secondary dysmenorrhea (e.g. endometriosis, salpingitis, adhesions)
- Hypersensitivity to HBB or other components of HBB (e.g., lactose) or ibuprofen or other components (e.g., fructose) of the study drugs, including aspirin sensitive asthma or previous allergic response to an NSAID.
- Known and/or untreated narrow-angle glaucoma, tachyarrhythmia, megacolon, myasthenia gravis, mechanical stenosis in the gastrointestinal tract, paralytic or obstructive ileus, unsolved blood-formation disorders, active or history of recurrent peptic ulcer or hemorrhage (2 or more distinct episodes of proven ulceration or bleeding), gastrointestinal bleeding or perforation, related to previous NSAID therapy (according to anamnesis), cerebrovascular or other active bleeding, severe liver or renal function disorder.
- Any other medical condition that would interfere with efficacy and safety assessments based on Investigator’s judgment, such as for example ulcerative colitis, Crohn's disease, uncontrolled hypertension, cardiac insufficiency (NYHA II-III), significant arrhythmia, existing ischemic heart disease, peripheral arterial occlusive disease and/or cerebrovascular disease, disturbances of porphyrin metabolism, Systemic Lupus Erythematosus as well as mixed connective tissue disease.
- Use of medication interfering with study drugs (e.g., acetylsalicylic acid and other pain medications like anti-inflammatory drug (NSAID), digoxin-, phenytoin- or lithium, glucocorticoids (oral), warfarin or other anticoagulants, selective serotonin reuptake inhibitors as well as other, psychotropic drugs, antidepressants, and sedative-hypnotics). Hormonal contraception is prohibited.
- History of hepatic disorder or significant coagulation defect, history of thrombosis.
- Participation in another clinical trial within the past 30 days or 5 x the half-life of any investigational drug, whichever is longer.
- Present pregnancy and lactation or failing to take adequate contraceptive precautions (other than hormonal therapy).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of hyoscine butyl bromide co-administered with ibuprofen, compared with placebos, for treating participants suffering from lower abdominal cramps in primary dysmenorrhea, based on SPID0-6 post dosing of the first study treatment intake on Day 1;Secondary Objective: - To assess the safety of hyoscine butyl bromide co-administered with ibuprofen, for treating participants suffering from PD<br>- To evaluate the efficacy of hyoscine butyl bromide co-administered with ibuprofen, based on other efficacy variables post dosing of the first study treatment intake on Day 1.<br>;Primary end point(s): Pain Intensity ; Sum of Pain Intensity Difference over 6 hours post dosing (SPID0-6) of the first study treatment intake on Day 1 of each evaluation period, in Numerical Rating Scale (0-to-10 NRS) for abdominal cramping pain.;Timepoint(s) of evaluation of this end point: First intake on Day 1 of each evaluation period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 - Adverse events ; Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs<br>2 - Total Pain Relief ; Total Pain Relief (TOTPAR 0-6)<br>3 - Pain Intensity Difference PID ; Time course of Pain Intensity Difference PID <br>4 - Pain relief ; Time course of pain relief <br>5 - Pain Intensity ; Sum of Pain Intensity Difference SPID0-4;Timepoint(s) of evaluation of this end point: 1 - from ICF signature to end of study <br>2, 3, 4 - First intake on D1 in each period ( 6 hours post dosing)<br>5 - First intake on D1 in each period ( 4 hours post dosing)