A four-week Double-blind, Placebo-controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of AF219 in Female Subjects with Bladder Pain Syndrome
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 Schedule of assessments and
Procedures is located at the end of this Synopsis. The study will consist of 4 phases: up to 14-day Screening Phase, an up to 7- day (but at least 4-day) Baseline assessment Phase, a 4-week Treatment Phase,
and a 2-week Follow-up Phase. Subjects who satisfy entry criteria at Screening will enter the up to 7-day
Baseline assessment Phase during which subjects will complete a daily numeric Pain Rating Scale (nPRS) (average and worst) and use of rescue medication via interactive Voice Response System (iVRS) for the preceding
24-hour period each evening. on any 3 consecutive days of the Baseline assessment Phase, the subjects will also complete a daily diary of urinary symptom assessments. up to 150 subjects who meet entry criteria will be
randomized to one of the following treatment groups in an equal ratio (1:1 allocation):
* Test Drug: aF-219 300 mg BiD
* Placebo: Matching placebo BiD
Subjects will undergo baseline assessments and receive study drug (first dose to be taken on the morning after Baseline Visit).
During the 4-week double-blind Treatment Phase, subjects will take study drug or matching placebo approximately every 12 hours with food. Subjects will complete a daily nPRS (average and worst) and use of rescue
medication via iVRS for the preceding 24-hour period each evening. on any 3 consecutive days during each week of the Treatment Phase, the subjects will also complete a daily diary of urinary symptom assessments. Subjects
complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. at each Treatment Visit, subjects will undergo efficacy assessments and safety procedures.
Subjects will return 2 weeks after their last Treatment Visit (Week 4 or early Withdrawal) for a Follow-up Visit.
Subjects who meet all of the following criteria will be included in the study:
1. Women between 18 and 80 years of age inclusive
2. Women of child-bearing potential (i.e., women not surgically sterile or not post-menopausal (defined as no menses for at least 12 months) with a negative pregnancy test at Screening, Baseline Visit, and each Treatment Visit and prior to xray exams. Tubal ligation is not considered an adequate form of sterilization and such subjects are considered to be of child-bearing potential.
3. Women of child-bearing potential must use 2 forms of acceptable birth control method from Screening through the Follow-Up Visit. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD)
or intrauterine system (IUS); tubal ligation; or male sterilization (with post-vasectomy documentation of the absence of sperm). Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth
control. When in line with the preferred life style of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
4. Clinical evidence of IC/BPS defined by:
a. Complaint of pelvic pain, pressure, or discomfort perceived to be related to the urinary bladder accompanied by urinary frequency (due to pain, pressure, or discomfort, not due to fear of wetting) for at least the past 6 months with symptoms present for the majority of the time during the most recent 3 months
5. Moderate to severe IC/BPS symptom severity defined by:
a. O[Single Quote]Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score >=7 at Screening
6. Moderate to severe pain and urinary frequency during the Baseline Assessment Phase:
a. Completed at least 4 days of the daily NPRS and have had a mean daily [?]average pain[Single Quote] rating of >=4 and <10 on the 11-point numerical rating scale (0 = no pain to 10 = worst possible pain) during the Baseline Assessment Phase
b. Completed 3 consecutive daily urinary symptom assessments and have had a mean number of voids per day >=8 during the Baseline Assessment Phase
7. IC/BPS should be the predominant pain condition and subject should be able to easily differentiate from other conditions, such as symptoms of irritable bowel syndrome
8. Have provided written informed consent
9. Are willing and able to comply with all aspects of the protocol