N/A Completed N=3,109

Toviaz Post Marketing Surveillance Study

Overactive Bladder

Source: ClinicalTrials.gov NCT00879398 ↗

Enrolled (actual)

3,109

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 8.53 Percentage of Participants

Summary

The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	8.53	—
PRIMARY Investigator's Final Assessment of Effectiveness at the End of Study Treatment	90.13; 9.50; 0.37	—
SECONDARY Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment	12.05; 8.04; -4.02	<0.0001 sig
SECONDARY Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment	3.65; 1.27; -2.37	<0.0001 sig
SECONDARY Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment	1.07; 0.27; -0.80	<0.0001 sig
SECONDARY Participant Perception of Bladder Condition at the End of Study Treatment	0; 0; 0; 1; 0; 0	—
SECONDARY Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics	90.13; 90.86; 89.20; 91.27; 91.08; 89.29	0.1319

Eligibility Criteria

Inclusion Criteria

Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.

Exclusion Criteria

Hypersensitivity to the active substance or to peanut or soya or any of the excipients
Urinary retention
Gastric retention
Uncontrolled narrow angle glaucoma
Myasthenia gravis
Severe hepatic impairment (Child Pugh C)
Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
Severe ulcerative colitis
Toxic megacolon
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00879398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.