Overactive bladder (OAB) MedDRA version: 8.1 Level: LLT Classification code 10059617
Conditions
Interventions
Product Name: SVT-40776 capsules
Pharmaceutical Form: Prolonged-release capsule, hard
Current Sponsor code: SVT-40776
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration
Sponsors
Laboratorios SALVAT, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility will be based on the presence of symptoms of OAB and a willingness to participate in the study. Screening Visit: Patients fulfilling the following criteria at this visit are eligible for participation in the study: •Male or female patients aged 18 to 80 years. Female patients must be of non child-bearing potential or using effective contraception, e.g. use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 2 weeks after study completion. Pregnancy testing and birth control measures are required for younger women who are amenorrheic for >12 months without confirmation of surgical sterilization or postmenopausal status by FSH levels. •Females of childbearing potential, including those currently using accepted forms of reliable contraception, must have a negative pregnancy test prior to enrolment and not be, in the opinion of the investigator, at appreciable risk of becoming pregnant. •Patients suffering from OAB based on three cardinal symptoms (urgency with or without urge incontinence, usually accompanied by frequency or nocturia) for at least 6 months prior to inclusion. •Patients must be able to adhere to the study visit schedule and other protocol requirements. •Patients must be able and willing to correctly and independently complete their diary cards. •Patients must be able to use the toilet without assistance. •Patients must understand and voluntarily sign informed consent before screening, following an explanation of the nature and purpose of this study. Visit 1 (Day 0) - (start of double-blind treatment period): Patients must continue to fulfil the Screening visit criteria for participation in the study. In addition, patients fulfilling both the following criteria at this visit are eligible for randomisation to the double-blind period of the study: •Patients who document, during the 14 day placebo run-in period, an average of = 10 micturitions/ 24 hours in the patient diary (recorded for the last three consecutive days before Visit 1). •Patients who document, during the 14 day placebo run-in period, either a total of = 3 incontinence episodes or a total of = 3 urgency episodes in the patient diary (recorded for the last three consecutive days before Visit 1). Are the trial subjects under 18? 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Screening visit: •Clinically significant bladder neck obstructions defined as post-void residual urine volumes greater than 100 mL. •Peak free uroflow 21 mmHg. •Any contraindication to antimuscarinic drugs (e.g. urinary retention). •Patients who in the past 3 months have undergone and/ or are anticipated to begin or change to other non-medicinal therapies such as lower urinary tract rehabilitation, electrical stimulation, catheterisation, bladder reflex triggering or bladder expression. •History of chronic alcoholism or drug addiction in the preceding 6 months. • Concomitant medications that, in the investigator’s opinion, would interfere with patient’s suitability and/or effective participation in the trial. • Patients participating in another clinical trial or receiving a non-approved drug in the 4 weeks before the Screening visit. Visit Day 14: •Active urinary tract infection, i.e. screening urinalysis must be negative. •Uninvestigated haematuria. •Clinically significant abnormal laboratory values (haematology, clinical chemistry). •Positive serology for Hepatitis B or Hepatitis C. Known positive test for HIV (human immunodeficiency virus). •Females who are pregnant, breast feeding, or of child-bearing po
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-response relationship of SVT-40776 on efficacy;Primary end point(s): The primary efficacy endpoint will be the change in the number of micturitions per 24 hours from baseline to the end of the double-blind treatment period.;Secondary Objective: 1) To compare 4 weeks efficacy of different doses of SVT-40776 to that of placebo in patients suffering from OAB. 2) To compare the tolerability of different doses of SVT-40776 to that of placebo in patients suffering from OAB. 3) To compare 4 weeks efficacy and tolerability of tolterodine 4 mg to that of placebo in patients suffering from OAB. 4) To obtain exposure-response data of SVT-40776 in a subgroup of patients. | — |
Countries
Czech Republic, Germany, Hungary, Netherlands, Spain
Outcome results
None listed