NCT01882543

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 5, 2017

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

June 18, 2013

Results QC Date

May 5, 2017

Last Update Submit

August 3, 2017

Conditions

Interstitial CystitisBladder Pain Syndrome

Keywords

Interstitial cystitisBladder pain syndromeIC/BPSAQX-1125SHIP1

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)

    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'.

    Baseline to Week 6

Secondary Outcomes (7)

  • Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)

    Baseline to Week 6

  • Change From Baseline in the Average Bladder Pain Score (Clinic)

    Baseline to Week 6

  • Change From Baseline in the Maximum Bladder Pain Score (Clinic)

    Baseline to Week 6

  • Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]

    Baseline to Week 6

  • O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]

    Baseline to Week 6

  • +2 more secondary outcomes

Other Outcomes (1)

  • AQX-1125 Concentrations in Plasma and Urine (Trough Values)

    Week 4 and Week 6

Study Arms (2)

AQX-1125

EXPERIMENTAL

1 x AQX-1125 Capsule daily

Drug: AQX-1125

Placebo

PLACEBO COMPARATOR

1 x placebo capsule daily

Drug: Placebo

Interventions

AQX-1125DRUG

Synthetic SHIP1 activator

AQX-1125
PlaceboDRUG

Double blind placebo capsule

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

AQX/CMX site

Homewood, Alabama, 35209, United States

Location

AQX/CMX site

Glendora, California, 91741, United States

Location

AQX/CMX site

San Diego, California, 92123, United States

Location

AQX/CMX site

Denver, Colorado, 80211, United States

Location

AQX/CMX site

Farmington, Connecticut, 06032, United States

Location

AQX/CMX site

Orlando, Florida, 32801, United States

Location

AQX/CMX site

Shreveport, Louisiana, 71106, United States

Location

AQX/CMX site

Troy, Michigan, 48084, United States

Location

AQX/CMX site

Garden City, New York, 11530, United States

Location

AQX/CMX Site

Winston-Salem, North Carolina, 27103, United States

Location

AQX/CMX site

Toledo, Ohio, 43615, United States

Location

AQX/CMX site

DeSoto, Texas, 75115, United States

Location

AQX/CMX site

Calgary, Alberta, T2V1P9, Canada

Location

AQX/CMX site

Kelowna, British Columbia, Canada

Location

AQX/CMX Site

Vancouver, British Columbia, V6Z1Y6, Canada

Location

AQX/CMX site

Victoria, British Columbia, Canada

Location

AQX/CMX site

Halifax, Nova Scotia, B3H2Y9, Canada

Location

AQX/CMX site

Barrie, Ontario, Canada

Location

AQX/CMX site

Brampton, Ontario, Canada

Location

AQX/CMX site

Brantford, Ontario, Canada

Location

AQX/CMX site

Burlington, Ontario, Canada

Location

AQX/CMX site

Kingston, Ontario, Canada

Location

AQX/CMX site

Kitchener, Ontario, Canada

Location

AQX/CMX site

Oakville, Ontario, Canada

Location

AQX/CMX site

Toronto, Ontario, Canada

Location

Dr Lesley Carr

Toronto, Ontario, Canada

Location

AQX/CMX site

Granby, Quebec, Canada

Location

AQX/CMX site

Montreal, Quebec, Canada

Location

AQX/CMX site

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

  • Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

    PMID: 32734597DERIVED

Related Links

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
J. Curtis Nickel
Organization
Department of Urology, Queens University, Ontario
jcn@queensu.ca
613-548-2497

Study Officials

  • Stephen B Shrewsbury, MD

    Aquinox Pharmaceuticals (Canada) Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 20, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 5, 2017

Results First Posted

September 5, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(17)US(12)