E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013935 |
E.1.2 | Term | Dysmenorrhoea |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
- To assess the safety of hyoscine butyl bromide co-administered with ibuprofen, for treating participants suffering from PD - 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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.
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E.4 | Principal exclusion criteria |
- 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). |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First intake on Day 1 of each evaluation period |
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E.5.2 | Secondary end point(s) |
1 - Adverse events ; Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs 2 - Total Pain Relief ; Total Pain Relief (TOTPAR 0-6) 3 - Pain Intensity Difference PID ; Time course of Pain Intensity Difference PID 4 - Pain relief ; Time course of pain relief 5 - Pain Intensity ; Sum of Pain Intensity Difference SPID0-4 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - from ICF signature to end of study 2, 3, 4 - First intake on D1 in each period ( 6 hours post dosing) 5 - First intake on D1 in each period ( 4 hours post dosing) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |