The Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis /Bladder Pain Syndrome

This study is currently recruiting participants.

Verified January 2013 by Afferent Pharmaceuticals, Inc.

Sponsor:

Information provided by (Responsible Party):

Afferent Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01569438

First received: March 30, 2012

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 30, 2012
Last Updated Date	January 23, 2013
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 2, 2012)	The primary efficacy endpoint of this study is change from Baseline in the 'average pain' NPRS score. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01569438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 2, 2012)	Numeric Pain Rating Scale Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] Genitourinary Pain Index (GUPI) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis /Bladder Pain Syndrome
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to assess the efficacy of a single dose level of AF-219 in female subjects with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.
Detailed Description	This study is a double-blind, placebo-controlled, randomized trial designed to assess the efficacy and safety of a single dose level of AF-219 in female subjects with moderate to severe IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Bladder Pain Syndrome
Intervention ^ICMJE	Drug: AF-219 BID Drug: Sugar Pill Placebo
Study Arm (s)	Experimental: AF-219 Intervention: Drug: AF-219 Placebo Comparator: Sugar Pill Intervention: Drug: Sugar Pill
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	September 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women Women of child bearing potential must not be pregnant during the study and must use two forms of birth control Clinical evidence of IC/BPS Have provided written informed consent Exclusion Criteria: History of diseases that can be confused for IC/BPS Unable to void spontaneously Immunosuppressant, intravesicular, nerve stimulator or opioid treatment during the study and for certain periods prior to start of the study. Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1 antagonist, or anti-muscarinic treatment within a certain period prior to the start of the study.
Gender	Female
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01569438
Other Study ID Numbers ^ICMJE	AF219-005
Has Data Monitoring Committee	Not Provided
Responsible Party	Afferent Pharmaceuticals, Inc.
Study Sponsor ^ICMJE	Afferent Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Afferent Pharmaceuticals, Inc.
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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