Administration of Mirabegron 50mg in patients with neurogenic bladder

• Register: EUCTR
• Last refreshed on: 17 May 2016
• Main ID: EUCTR2014-002592-29-CZ
• Date of registration: 29/12/2014
• Prospective Registration: Yes
• Primary sponsor: Fakultní nemocnice Ostrava
• Public title: Administration of Mirabegron 50mg in patients with neurogenic bladder
• Scientific title: A randomized, double blind, placebo controlled study to evaluate the efficacy and safety of mirabegron 50 mg versus placebo in patients with neurogenic detrusor overactivity - MIRAGE
• Date of first enrolment: 17/04/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002592-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic

Contacts

• Name: Department of Urology
• Affiliation: University hospital Ostrava

• Name: Department of Urology
• Affiliation: University hospital Ostrava

Key inclusion & exclusion criteria

Inclusion criteria:
Patients with the proved neurogenic detrusor overactivity NDO with complete or incomplete spinal cord injury or multiple sclerosis
Symptoms of NDO stable of at least 6 month
Patient able and willing to take the study medication according to the protocol
Patient able and willing to attend all examinations according to the protocol

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 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients with the NDO of other origin than studied
Patients with symptomatic infection of urinary tract
Patients with interstitial cystitis, stones
Patients with bladder cancer or after radiation therapy in pelvis
Patients with severe renal or hepatic impairement
Patients with severe or nontreated hypertension




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Spinal cord injury Multiple sclerosis

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Betmiga
Product Name: Betmiga
Pharmaceutical Form: Coated tablet
INN or Proposed INN: mirabegron
CAS Number: 223673-61-8
Other descriptive name: MIRABEGRON
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To assess the safety of the mirabegron 50mg compairing with the placebo in patients with NDO
To assess the mirabegron 50mg effect against placebo on the quality of the life

Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation

Main Objective: Exploration of the mirabegron 50mg efficacy compaired to placebo in patients with NDO

Primary end point(s): Change of maximal cystometric capacity

Secondary Outcome(s)

Secondary end point(s): Change in the volume of the nonvoiding contraction
Change of the maximal detrusor pressure
Change of the detrusor compliance
Change in the 24hours pad-weight test
Change in the i-QOL score
Change in the PPBC score
Change in the VAS TS score

Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation

Secondary ID(s)

MIR-2014

Source(s) of Monetary Support

ASTELLAS