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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01569438
First received: March 30, 2012
Last updated: June 12, 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
Study Completion Date: June 2014
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 12, 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 August 27, 2014