Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01882543 |
Date of registration:
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18/06/2013 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and Safety of AQX-1125 in IC/BPS
LEADERSHIP |
Scientific title:
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A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway |
Date of first enrolment:
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June 2013 |
Target sample size:
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69 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01882543 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Stephen B Shrewsbury, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Aquinox Pharmaceuticals (Canada) Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be females, =18 and =75 years of age, who have consistently had symptoms of bladder
pain in addition to urinary urgency and/or urinary frequency for more than 12 months
- Have had the diagnosis of interstitial cystitis for > 6 months (pain for at least 12
months) but =15 years
- Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating
Scale [NRS] pain scale in the 9 days prior to baseline
- Have undergone a cystoscopy and have documented visible signs of bladder bleeding,
lesions or glomerulation within the last 36 months prior to baseline.
- Subjects if of child bearing potential, must agree to avoid pregnancy and use
medically acceptable method of contraception from screening visit and throughout the
study.
- Must be capable of voiding independently
Exclusion Criteria:
- Pelvic floor pain (>5 out of 10 on the 11-point NRS pain scale following a pelvic pain
assessment)
- Have a body mass index [BMI] of <18 kg/m2 or >39 kg/m2
- Have had a urinary tract infection including bacterial cystitis within the past 30
days.
- Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
- History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis)
that has affected bladder function
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Bladder Pain Syndrome
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Intervention(s)
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Drug: AQX-1125
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Drug: Placebo
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Primary Outcome(s)
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Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)
[Time Frame: Baseline to Week 6]
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Secondary Outcome(s)
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Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]
[Time Frame: Baseline to Week 6]
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Change From Baseline in the Maximum Bladder Pain Score (Clinic)
[Time Frame: Baseline to Week 6]
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Change From Baseline in the Average Bladder Pain Score (Clinic)
[Time Frame: Baseline to Week 6]
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Voiding Frequency as Recorded by Diary Over a 24 Hour Period
[Time Frame: Baseline to Week 6]
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Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)
[Time Frame: Baseline to Week 6]
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O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]
[Time Frame: Baseline to Week 6]
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Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire
[Time Frame: Baseline to Week 6]
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Secondary ID(s)
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AQX-1125-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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