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

This study is currently recruiting participants.
Verified January 2014 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 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Bladder Pain Syndrome
Drug: AF-219
Drug: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Afferent Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AF-219 Drug: AF-219
BID
Placebo Comparator: Sugar Pill Drug: Sugar Pill
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569438

  Show 42 Study Locations
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01569438     History of Changes
Other Study ID Numbers: AF219-005
Study First Received: March 30, 2012
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystitis, Interstitial
Somatoform Disorders
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014