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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01882543
First Posted: June 20, 2013
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aquinox Pharmaceuticals (Canada) Inc.
  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: Quadruple (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 Average Daily Bladder Pain Score (e-Diary) [ Time Frame: Baseline to Week 6 ]
    Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.


Secondary Outcome Measures:
  • Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary) [ Time Frame: Baseline to Week 6 ]
    Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

  • Change From Baseline in the Average Bladder Pain Score (Clinic) [ Time Frame: Baseline to Week 6 ]
    Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visit. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

  • Change From Baseline in the Maximum Bladder Pain Score (Clinic) [ Time Frame: Baseline to Week 6 ]
    Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visits. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

  • Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS] [ Time Frame: Baseline to Week 6 ]
    Change in baseline to week 6 in the BPIC-SS participant reported questionnaire total score. The total BPIC-SS score ranges from 0-38, with a higher score indicative of worse symptoms. A score of 19 or more was considered to be discriminating between IC/BPS and overactive bladder at screening.

  • O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] [ Time Frame: Baseline to Week 6 ]
    Change from baseline to week 6 in the O'Leary Sant Symptom and Problem Index combined total scores. Both the ICSI and ICPI consist of 4 questions with responses for the ICSI rated on a scale of 0-5 (maximum score of 20, with a higher score indicating worse symptoms) and for the ICPI on a scale of 0-4 (maximum score of 16, with a higher score indicating worse symptoms). For the combined ICSI/PI the maximum score is 36, with a higher score indicating worse symptoms.

  • Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire [ Time Frame: Baseline to Week 6 ]
    Change from baseline to week 6 in the SF-12v2 questionnaire. Two parameters, PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better Quality of Life.

  • Voiding Frequency as Recorded by Diary Over a 24 Hour Period [ Time Frame: Baseline to Week 6 ]
    For a 24-hour period (within 3 days of the subsequent visit), subjects recorded the frequency of each void prior to visit. The outcome measure was the change from baseline at week 6.


Other Outcome Measures:
  • AQX-1125 Concentrations in Plasma and Urine (Trough Values) [ Time Frame: Week 4 and Week 6 ]
    AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 (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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 18, 2013
First Posted: June 20, 2013
Results First Submitted: May 5, 2017
Results First Posted: September 4, 2017
Last Update Posted: September 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Cystitis, Interstitial
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases