NCT00380783

Brief Summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with painful bladder syndrome/interstitial cystitis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

5 months

First QC Date

September 22, 2006

Last Update Submit

May 27, 2011

Conditions

Cystitis, Interstitial

Outcome Measures

Primary Outcomes (1)

  • Reduction in daily pain scores

Interventions

AGN 203818DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of painful bladder syndrome/interstitial cystitis
  • Moderate or severe bladder pain

You may not qualify if:

  • Any other uncontrolled disease
  • Pregnant or nursing females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 26, 2006

Study Start

October 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(1)