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Efficacy and Safety of AQX-1125 in IC/BPS (LEADERSHIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aquinox Pharmaceuticals (Canada) Inc.
ClinicalTrials.gov Identifier:
NCT01882543
First received: June 18, 2013
Last updated: November 20, 2015
Last verified: November 2015
  Purpose
The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary

Condition Intervention Phase
Interstitial Cystitis Bladder Pain Syndrome Drug: AQX-1125 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aquinox Pharmaceuticals (Canada) Inc.:

Primary Outcome Measures:
  • Change from baseline in the mean daily bladder pain score [ Time Frame: 6 weeks (also at 2 and 4 weeks) ]
    Difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale [NRS] at 2, 4 and 6 weeks recorded by e-diary


Secondary Outcome Measures:
  • Difference in the change from baseline in other symptom scores and quality of life measures [ Time Frame: 2, 4 and 6 weeks ]
    Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS], interstitial cystitis symptom index/problem index [ICSI/PI] and short form 12 version 2.0 health survey [SF-12v2] questionnaires will be completed at start and end of treatment (and BPIC-SS at 2 and 4 weeks)

  • Safety determined by adverse events [AEs], physical examinations, laboratory tests, electrocardiogram [ECG] and ophthalmic examinations [ Time Frame: 10 weeks ]
    Adverse events will be collected from signing of informed consent until discharge from study. Other assessments will be completed at regular intervals


Other Outcome Measures:
  • AQX-1125 concentrations in plasma and urine (trough values) [ Time Frame: 10 weeks ]

Enrollment: 69
Study Start Date: June 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AQX-1125
1 x AQX-1125 Capsule daily
Drug: AQX-1125
Synthetic SHIP1 activator
Placebo Comparator: Placebo
1 x placebo capsule daily
Drug: Placebo
Double blind placebo capsule

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 (but 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 NRS pain scale in the 7 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
  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: NCT01882543

  Show 29 Study Locations
Sponsors and Collaborators
Aquinox Pharmaceuticals (Canada) Inc.
Investigators
Study Director: Stephen B Shrewsbury, MD Aquinox Pharmaceuticals (Canada) Inc.
  More Information

Additional Information:
Responsible Party: Aquinox Pharmaceuticals (Canada) Inc.
ClinicalTrials.gov Identifier: NCT01882543     History of Changes
Other Study ID Numbers: AQX-1125-201
Study First Received: June 18, 2013
Last Updated: November 20, 2015

Keywords provided by Aquinox Pharmaceuticals (Canada) Inc.:
Interstitial cystitis
Bladder pain syndrome
IC/BPS
AQX-1125
SHIP1

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Cystitis, Interstitial
Cystitis
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 28, 2017