Study of ONO-8539 in Patients With Overactive Bladder

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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

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

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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