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SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)

NCT00409539 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2014-12-10

Study results available
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Summary

SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

Conditions

  • Overactive Bladder Syndrome (OABS)

Interventions

DRUG

Placebo

Placebo, 2 week duration.

DRUG

Placebo

Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).

DRUG

SMP-986

Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks

Sponsors & Collaborators

  • Dainippon Sumitomo Pharma America

    collaborator INDUSTRY

  • ICON Clinical Research

    collaborator INDUSTRY

  • ClinPhone, Inc.

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof C Chappel · Royal Hallamshire Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • United States
  • Estonia
  • France
  • Germany
  • Latvia
  • Lithuania
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409539 on ClinicalTrials.gov