A Phase 4 interventional study of Darifenacin and Darifenacin in Urinary Incontinence, sponsored by Novartis. Completed at 67 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-24.
Sponsored by Novartis · Phase 4 and Interventional
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 395 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Darifenacin
Drug: Darifenacin
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Drug: Darifenacin · Behavioral: Behavioral therapy
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Also known as: Enablex
Darifenacin tablets 7,5 mg or 15 mg once daily
Behavioral Modification Programme for symptoms of overactive bladder
Change from baseline in average number of urinations per patient per day at Week 12
Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12
Quality of Life (baseline, Week 6, Week 12)
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Novartis