A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial Cystitis

• Register: EUCTR
• Last refreshed on: 12 May 2014
• Main ID: EUCTR2011-004555-39-NL
• Date of registration: 08/02/2012
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial Cystitis
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis - AMARANTH
• Date of first enrolment: 05/07/2012
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004555-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: adaptive design If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4

Countries of recruitment

Belgium, Czech Republic, Denmark, France, Germany, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain

Contacts

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
At Visit 1:
1. Written informed consent has been obtained. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Is female, 18 years of age or older and of Caucasian (white) ethnic background.
3. Has previously been diagnosed with BPS/IC; i.e, pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 3 months prior to screening in absence of urinary infection or other obvious pathology or identifiable causes.
4. Has a score of 4 or greater on the 11-point (0-10) NRS for average pain over the previous week, which is item 4 of the F GUPI.
5. Must practice a highly reliable method of birth control. When of childbearing potential, subjects must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices (IUDs), sexual abstinence or vasectomized partner.
6. Is willing and able to comply with study requirements (e.g, complete questionnaires and diaries) and attend all required study visits.

At randomization (Visit 2/BV), the subject
7. Is confirmed to have at least moderate pain as reflected by a MDP of at least 4.0. The MDP is the mean of 7 consecutive daily assessments of average pain on an 11 point (0-10) NRS with a recall period of 24 hours (item 4 of F GUPI-24h).
8. Is confirmed to be willing to comply and has shown to be compliant with study requirements (such as completing questionnaires and diaries, compliance with study drug use and practicing a highly reliable method of birth control) and with attending all study visits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
1. A positive pregnancy test (?-HCG in serum) or be lactating.#
2. Undergone a CS with hydrodistension or undergone Botox injections in the bladder within 6 months prior to the screening visit.
3. Been treated with pentosan polysulphate sodium within 4 weeks prior to the screening visit.
4. Had any intravesicular pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide [DMSO]), or have had other interventions for BPS/IC (including electric stimulation therapy or acupuncture therapy) that may have affected disease symptoms within 3 months prior to the screening visit.
5. Cystitis (radiation cystitis, Bacillus Calmette-Guérin (BCG)-induced cystitis, bacterial / tuberculous cystitis, cyclophosphamide cystitis) or had a documented symptomatic bacterial cystitis in the last 3 months prior to the screening visit.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Bladder Pain Syndrome / Interstitial Cystitis
MedDRA version: 14.1 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1 Level: LLT Classification code 10008928 Term: Chronic interstitial cystitis NOS System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1 Level: LLT Classification code 10008927 Term: Chronic interstitial cystitis System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1 Level: PT Classification code 10011796 Term: Cystitis interstitial System Organ Class: 10038359 - Renal and urinary disorders

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Intervention(s)

Product Name: ASP3652
Product Code: ASP3652
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ASP3652
Current Sponsor code: ASP3652
Other descriptive name: ASP3652
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: ASP3652
Product Code: ASP3652
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ASP3652
Current Sponsor code: ASP3652
Other descriptive name: ASP3652
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To investigate efficacy of ASP3652 in female subjects with BPS/IC

Primary end point(s): Change from baseline (last week of Run-in) in MDP at week 12 (the week prior to Visit 6/EoT). MDP is the mean of 7 consecutive daily assessments of pain. Pain is assessed on an 11 point (0-10) NRS with a recall period of 24 hours, which is item 4 of the F-GUPI-24h as recorded by the subject in the electronic diary.

Secondary Objective: To assess the optimal dose of ASP3652 for the treatment of female subjects with BPS/IC.
To investigate safety and tolerability of ASP3652 in female subjects with BPS/IC.
To investigate the PK and PD of ASP3652 in female subjects with BPS/IC.

Timepoint(s) of evaluation of this end point: week 0, week 4, week 8, week 12, (week 14)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: week 0, week 4, week 8, week 12, (week 14)

Secondary end point(s): Change from baseline (Visit 2/BV) in F-GUPI Total score at week 12 (Visit 6/EoT).

Secondary ID(s)

3652-CL-0018

Source(s) of Monetary Support

Astellas Pharma Europe B.V.