The efficacy and safety of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea will be investigated. Primary dysmenorrhea is the most common gynecological complaint in reproductive women. It is characterized by painful uterine contraction or menstrual cramps, occurring during menstruation without pelvic pathologies. Pain usually occurs intensely on the first or second day or the first 24–36 hours of menstruation.
Conditions
Interventions
Product Name: ibuprofen plus hyoscine butylbromide
Product Code: Test
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ibuprofen
Current Sponsor code: Test
Concentration unit: mg milligram(s)
C
Sponsors
RONTIS HELLAS S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Female patients =18 and =40 years of age [2]Patients with a history of primary dysmenorrhea [3]Patients with moderate to severe pain in at least 5 of the last 6 menstrual cycles [4]Patients willing and able (e.g., mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent 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 54 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 hypersensitivity or intolerance to the active substances or any of the excipients of the study medication [2]History of hypersensitivity reactions (e.g., asthma, urticaria, angioedema or rhinitis) after taking other NSAIDs (e.g., acetylsalicylic acid or similar) [3]Any condition which might cause secondary dysmenorrhoea (e.g., endometriosis, salpingitis, adhesions) [4]Other likely causes of abdominal pain (e.g., gastric or peptic ulcer, inflammatory bowel disease, leiomyoma, pelvic inflammatory disease) [5]History of gastrointestinal bleeding [6]Conditions involving an increased tendency to bleeding [7]History of frequent dyspepsia, heartburn or indigestion [8]Severe heart failure (NYHA Class IV), hepatic failure and renal failure [9]Any of the following conditions: a)untreated narrow angle glaucoma, b)gastric outlet obstruction, c)intestinal atony, d)tachycardia, e)mechanical stenosis of the gastrointestinal tract, myasthenia gravis, f)megacolon [10]History of significant disease deemed by the investigator to render the patients unsuitable for inclusion [11]Concomitant major depression [12]Concomitant condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication [13]Previous (within 7 days before first study drug administration) intake or administration of analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea [14]Previous (within 7 days before first study drug administration) intake or administration of medications that might confound the assessment of pain relief, such as psychotropic drugs, antidepressants, sedative-hypnotics, NSAIDs, muscle relaxants* [15]Intake of oral contraceptives during the last 2 menstrual cycles preceding the trial [16]Administration of hormonal contraceptive devices during the last 2 menstrual cycles preceding the trial [17]Administration of long-acting depot contraceptives within the last 6 months preceding the trial [18]Patient is currently enrolled in, or has completed less than 30 days before the screening examination of the present trial another clinical trial with an investigational drug [19]Previous enrolment in this study [20]Pregnant or breast-feeding women [21]Women of childbearing potential unable or unwilling to undergo pregnancy tests and to practice adequate contraceptive measures. Reliable methods for women during the trial are: a)combination of 2 barrier methods: female/male condoms, diaphragms, spermicides b)surgical intervention (e.g., tubal ligation), c)non-hormonal intrauterine device (IUD) d)sexual abstinence [22]Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study [23]Alcohol/drug dependence or abuse (excluding tobacco abuse) [24]Unreliability or lack of cooperation [25]Any other condition of the patient (e.g., serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a combination of ibuprofen plus hyoscine butylbromide as compared to ibuprofen alone and hyoscine butylbromide alone for the management of pain due to primary dysmenorrhea.;Secondary Objective: To evaluate the tolerability of ibuprofen plus hyoscine butylbromide;Primary end point(s): Area under the curve from 0 to 4 hours after each of the first two doses (AUC0-4h) for the pain intensity differences (pre-dose - post dose);Timepoint(s) of evaluation of this end point: before intake as well as 10, 20, 30, 40, 50, 60 minutes and 1.5, 2, 3, 4 hours after each of the first 2 doses of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Area under the curve from 0 to 2 hours after each of the first two doses for the pain intensity differences (pre-dose - post dose) • Area under the curve from 0 to 6 hours after each of the first two doses for the pain intensity differences (pre-dose - post dose) • Partial areas under the curve: 0 to 1 hour, 1 to 2 hours, and 2 to 6 hours after each of the first two doses for the pain intensity differences (pre-dose - post dose) • Pain intensity differences (pre-dose - post dose) at each of the pre-defined points in time: 10, 20, 30, 40, 50, 60 minutes and 1.5, 2, 3, 4, 5, and 6 hours after each of the first two doses of study medication • Percentage of patients who reach at least 30% reduction in pain intensity after each of the first two doses • Percentage of patients who reach at least 50% reduction in pain intensity after each of the first two doses • Time to at least 30% reduction in pain intensity after each of the first two doses • Time to at least 50% reduction in pain intensity after each of the first two doses • Number of patients using rescue medication within the first 2 hours post dose • Number of patients using rescue medication within the entire duration of treatment • Patient’s global ratings of pain relief;Timepoint(s) of evaluation of this end point: • from 0 to 2 hours after each of the first two doses • from 0 to 6 hours after each of the first two doses • 0 to 1 hour, 1 to 2 hours, and 2 to 6 hours after each of the first two doses • 10, 20, 30, 40, 50, 60 minutes and 1.5, 2, 3, 4, 5, and 6 hours after each of the first two doses of study medication • after each of the first two doses • within the first 2 hours post dose • entire duration of treatment | — |
Countries
Bulgaria
Contacts
Public ContactProject Manager
RONTIS HELLAS S.A.
Outcome results
None listed