Study of ONO-8539 in Patients With Overactive Bladder

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: ONO-8539; Drug: Placebo; Drug: Tolterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876421

ONO-8539POE004

Details and patient eligibility

About

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Enrollment: 435 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with medical history of Overactive Bladder symptoms for > 6 months

Exclusion criteria

• Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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435 participants in 5 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: Placebo

A

Active Comparator group

Treatment:

Drug: Tolterodine

E1

Experimental group

Treatment:

Drug: ONO-8539

E2

Experimental group

Treatment:

Drug: ONO-8539

E3

Experimental group

Treatment:

Drug: ONO-8539