Back to resultsEfficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome (LEADERSHIP 301)
Primary Purpose
Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AQX-1125 100 mg
AQX-1125 200 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Bladder pain syndrome, Painful bladder syndrome, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), AQX-1125, SHIP1, Chronic interstitial cystitis
Eligibility Criteria
Inclusion Criteria:
- Be male or female, ≥18 and ≤80 years of age who have had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 6 months
- Have had a clinical diagnosis, or history consistent with the diagnosis, of interstitial cystitis/bladder pain syndrome for >3 months but ≤20 years
- Must be capable of voiding independently
- Have undergone a cystoscopy within the last 36 months prior to Baseline
- Women of child bearing potential must have a negative pregnancy test, be non-lactating and agree to avoid pregnancy and use a highly effective method of contraception with one additional barrier method of contraception from screening until at least 28 days after the last dose of study drug has been taken
- Men must use a condom for sexual intercourse from screening until at least 90 days after last dose of study drug has been taken, unless they have been surgically sterilized (vasectomy)
Exclusion Criteria
- Have had a urinary tract infection (UTI) including bacterial cystitis within the past 30 days
- Microscopic hematuria that has not been adequately evaluated as per local standard of care
- Have a history of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
- History of previous procedure(s) (augmentation cystoplasty, cystectomy, cytolysis, botulinum toxin or bladder catheterization) that has significantly affected bladder function
- History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis
- Women: History of bladder tumors; uterine, cervical, vaginal or urethral cancer
- Men: History of prostate surgery (transurethral resection of the prostate [TURP], transurethral resection tumor [TURT], transurethral incision of the prostate [TUIP], transurethral needle ablation [TUNA] etc.), a history of prostate cancer or currently being treated for chronic bacterial prostatitis
- Major surgery within 3 months prior to Screening
Sites / Locations
- Site 9035
- Site 9026
- Site 9064
- Site 9010
- Site 9060
- Site 9011
- Site 9021
- Site 9019
- Site 9023
- Site 9015
- Site 9039
- Site 9003
- Site 9046
- Site 9070
- Site 9004
- Site 9029
- Site 9013
- Site 9049
- Site 9054
- Site 9007
- Site 9038
- Site 9005
- Site 9028
- Site 9034
- Site 9020
- Site 9042
- Site 9072
- Site 9062
- Site 9001
- Site 9025
- Site 9041
- Site 9016
- Site 9066
- Site 9037
- Site 9068
- Site 9002
- Site 9055
- Site 9045
- Site 9058
- Site 9048
- Site 9033
- Site 9047
- Site 9051
- Site 9053
- Site 9071
- Site 9050
- Site 9031
- Site 9036
- Site 9032
- Site 9040
- Site 9027
- Site 9069
- Site 9030
- Site 9052
- Site 9012
- Site 9008
- Site 1103
- Site 1102
- Site 1101
- Site 1013
- Site 1005
- Site 1006
- Site 1002
- Site 1003
- Site 1015
- Site 1010
- Site 1017
- Site 1017
- Site 1016
- Site 1008
- Site 2002
- Site 2006
- Site 2003
- Site 2001
- Site 2007
- Site 2004
- Site 2005
- Site 3002
- Site 4004
- Site 4001
- Site 4003
- Site 5005
- Site 5001
- Site 5002
- Site 5003
- Site 5004
- Site 1301
- Site 1302
- Site 6011
- Site 6009
- Site 6004
- Site 6005
- Site 6001
- Site 6007
- Site 6002
- Site 6003
- Site 6008
- Site 7007
- Site 7008
- Site 7002
- Site 7005
- Site 7009
- Site 7010
- Site 7004
- Site 7006
- Site 7011
- Site 7003
- Site 7001
- Site 1401
- Site 1402
- Site 1405
- Site 1403
- Site 8008
- Site 8001
- 8005
- Site 8007
- Site 8009
- Site 8004
- Site 8002
- Site 8003
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AQX-1125 100 mg
AQX-1125 200 mg
Placebo
Arm Description
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
2 placebo tablets, by mouth, once per day for 12 weeks; followed by randomization to 100 mg or 200 mg AQX-1125 for a 52-week Extension Period
Outcomes
Primary Outcome Measures
Change from Baseline in Maximum Daily Bladder Pain Score
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in the maximum daily bladder pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (e-diary)
Secondary Outcome Measures
Change from Baseline in Voiding Frequency Measured Over a 24 hr Period
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in voiding frequency measured over a 24-hour period
Change from Baseline Interstitial Cystitis Symptom Index Score
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Interstitial Cystitis Symptom Index Score
Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Bladder Pain/Interstitial Cystitis Symptom Score
Change from Baseline in Subject's Global Response Assessment
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in subject's Global Response Assessment
Full Information
NCT ID
NCT02858453
First Posted
April 19, 2016
Last Updated
March 13, 2018
Sponsor
Aquinox Pharmaceuticals (Canada) Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02858453
Brief Title
Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
Acronym
LEADERSHIP 301
Official Title
The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the Src Homology 2-containing Inositol-5'-Phosphatase 1 (SHIP1) Pathway in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aquinox Pharmaceuticals (Canada) Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52 weeks.
Detailed Description
This multi-center Phase 3 trial includes a randomized, double-blind, placebo-controlled, parallel-group, treatment phase to evaluate the efficacy and safety of 2 doses of oral AQX-1125 in up to 600 subjects with interstitial cystitis/bladder pain syndrome.
The primary objective of this study is to evaluate the effect of 12 weeks of treatment of AQX-1125 (100 mg or 200 mg) administered once daily compared to placebo on the change from Baseline to Week 12 in maximum daily bladder pain using a standardized 11-point numerical rating scale pain score recorded daily by electronic diary (e-diary).
The 12-week Treatment Period is followed by an Extension Period of 52 weeks. Randomization and start of dosing occurs at Baseline and is followed by visits at Week 6 and Week 12. At the end of Week 12, subjects will be randomized into the 52-week Extension Period. Subjects on active treatment during the Treatment Period will continue on that same dose for the Extension Period, while subjects receiving placebo during the Treatment Period will be randomized to one of the active doses of 100 mg or 200 mg AQX-1125 for 52 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, Chronic Interstitial Cystitis
Keywords
Interstitial cystitis, Bladder pain syndrome, Painful bladder syndrome, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), AQX-1125, SHIP1, Chronic interstitial cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
433 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AQX-1125 100 mg
Arm Type
Experimental
Arm Description
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
Arm Title
AQX-1125 200 mg
Arm Type
Experimental
Arm Description
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 placebo tablets, by mouth, once per day for 12 weeks; followed by randomization to 100 mg or 200 mg AQX-1125 for a 52-week Extension Period
Intervention Type
Drug
Intervention Name(s)
AQX-1125 100 mg
Intervention Description
Synthetic SHIP1 activator
Intervention Type
Drug
Intervention Name(s)
AQX-1125 200 mg
Intervention Description
Synthetic SHIP1 activator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Appearance and weight matched placebo tablets
Primary Outcome Measure Information:
Title
Change from Baseline in Maximum Daily Bladder Pain Score
Description
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in the maximum daily bladder pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (e-diary)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Voiding Frequency Measured Over a 24 hr Period
Description
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in voiding frequency measured over a 24-hour period
Time Frame
Baseline to 12 weeks
Title
Change from Baseline Interstitial Cystitis Symptom Index Score
Description
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Interstitial Cystitis Symptom Index Score
Time Frame
Baseline to 12 weeks
Title
Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score
Description
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Bladder Pain/Interstitial Cystitis Symptom Score
Time Frame
Baseline to 12 weeks
Title
Change from Baseline in Subject's Global Response Assessment
Description
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in subject's Global Response Assessment
Time Frame
Baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
Frequency and Severity of Adverse Events
Description
Adverse events and abnormal clinically significant vital signs, laboratory tests, electrocardiogram, weight, physical examination findings and ophthalmological examination findings
Time Frame
Baseline to 12-weeks; during 52-week EP and baseline to 64-weeks, with a 4-week post-dose, and 6 month post-dose (ocular only), follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be male or female, ≥18 and ≤80 years of age who have had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 6 months
Have had a clinical diagnosis, or history consistent with the diagnosis, of interstitial cystitis/bladder pain syndrome for >3 months but ≤20 years
Must be capable of voiding independently
Have undergone a cystoscopy within the last 36 months prior to Baseline
Women of child bearing potential must have a negative pregnancy test, be non-lactating and agree to avoid pregnancy and use a highly effective method of contraception with one additional barrier method of contraception from screening until at least 28 days after the last dose of study drug has been taken
Men must use a condom for sexual intercourse from screening until at least 90 days after last dose of study drug has been taken, unless they have been surgically sterilized (vasectomy)
Exclusion Criteria
Have had a urinary tract infection (UTI) including bacterial cystitis within the past 30 days
Microscopic hematuria that has not been adequately evaluated as per local standard of care
Have a history of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
History of previous procedure(s) (augmentation cystoplasty, cystectomy, cytolysis, botulinum toxin or bladder catheterization) that has significantly affected bladder function
History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis
Women: History of bladder tumors; uterine, cervical, vaginal or urethral cancer
Men: History of prostate surgery (transurethral resection of the prostate [TURP], transurethral resection tumor [TURT], transurethral incision of the prostate [TUIP], transurethral needle ablation [TUNA] etc.), a history of prostate cancer or currently being treated for chronic bacterial prostatitis
Major surgery within 3 months prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Moldwin, MD
Organizational Affiliation
Hofstra Northwell School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 9035
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Site 9026
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Site 9064
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Site 9010
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Site 9060
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Site 9011
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Site 9021
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Site 9019
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site 9023
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Site 9015
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site 9039
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Site 9003
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Site 9046
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91411
Country
United States
Facility Name
Site 9070
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Site 9004
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Site 9029
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Site 9013
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Site 9049
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Site 9054
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Site 9007
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Site 9038
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21114
Country
United States
Facility Name
Site 9005
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Site 9028
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Site 9034
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Site 9020
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Site 9042
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Site 9072
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Site 9062
City
Cranford
State/Province
New Jersey
ZIP/Postal Code
07016
Country
United States
Facility Name
Site 9001
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Site 9025
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Site 9041
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Site 9016
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Site 9066
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
Site 9037
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site 9068
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site 9002
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site 9055
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Site 9045
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site 9058
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site 9048
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Site 9033
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site 9047
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Site 9051
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Site 9053
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Site 9071
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Site 9050
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Site 9031
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Site 9036
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Site 9032
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Site 9040
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Site 9027
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Site 9069
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Site 9030
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 9052
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Site 9012
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Site 9008
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Site 1103
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Site 1102
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site 1101
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Site 1013
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 4V5
Country
Canada
Facility Name
Site 1005
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
Site 1006
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Site 1002
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Site 1003
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Site 1015
City
Oakville
State/Province
Ontario
ZIP/Postal Code
I6J 3P1
Country
Canada
Facility Name
Site 1010
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 3M5
Country
Canada
Facility Name
Site 1017
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Site 1017
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S2L6
Country
Canada
Facility Name
Site 1016
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Site 1008
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Site 2002
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Site 2006
City
Jablonec nad Nisou
ZIP/Postal Code
46601
Country
Czechia
Facility Name
Site 2003
City
Kolin
ZIP/Postal Code
28002
Country
Czechia
Facility Name
Site 2001
City
Pilsen
ZIP/Postal Code
30100
Country
Czechia
Facility Name
Site 2007
City
Prague
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Site 2004
City
Praha
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Site 2005
City
Uherske Hradiste
ZIP/Postal Code
68668
Country
Czechia
Facility Name
Site 3002
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Site 4004
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Site 4001
City
Csongrad
ZIP/Postal Code
6640
Country
Hungary
Facility Name
Site 4003
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Site 5005
City
Daugavpils
ZIP/Postal Code
LV-5401
Country
Latvia
Facility Name
Site 5001
City
Jelgava
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Site 5002
City
Liepaja
ZIP/Postal Code
LV-3402
Country
Latvia
Facility Name
Site 5003
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Site 5004
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Site 1301
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Site 1302
City
Den Haag
ZIP/Postal Code
2594 AB
Country
Netherlands
Facility Name
Site 6011
City
Bydgoszcz
ZIP/Postal Code
85-312
Country
Poland
Facility Name
Site 6009
City
Gdynia
ZIP/Postal Code
81-148
Country
Poland
Facility Name
Site 6004
City
Gdynia
ZIP/Postal Code
81-366
Country
Poland
Facility Name
Site 6005
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Site 6001
City
Poznan
ZIP/Postal Code
60-586
Country
Poland
Facility Name
Site 6007
City
Poznań
ZIP/Postal Code
61-512
Country
Poland
Facility Name
Site 6002
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Site 6003
City
Warsaw
ZIP/Postal Code
03889
Country
Poland
Facility Name
Site 6008
City
Warszawa
ZIP/Postal Code
00-714
Country
Poland
Facility Name
Site 7007
City
Braşov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Site 7008
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Site 7002
City
Bucharest
ZIP/Postal Code
14452
Country
Romania
Facility Name
Site 7005
City
Bucharest
ZIP/Postal Code
21655
Country
Romania
Facility Name
Site 7009
City
Bucharest
ZIP/Postal Code
41345
Country
Romania
Facility Name
Site 7010
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Site 7004
City
Bucuresti
ZIP/Postal Code
50659
Country
Romania
Facility Name
Site 7006
City
Craiova
ZIP/Postal Code
200349
Country
Romania
Facility Name
Site 7011
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Site 7003
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Site 7001
City
Târgu-Mureş
ZIP/Postal Code
540353
Country
Romania
Facility Name
Site 1401
City
Aravaca
ZIP/Postal Code
28023
Country
Spain
Facility Name
Site 1402
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Site 1405
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Site 1403
City
Vic
ZIP/Postal Code
08500
Country
Spain
Facility Name
Site 8008
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Site 8001
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
8005
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Site 8007
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Site 8009
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom
Facility Name
Site 8004
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Site 8002
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Site 8003
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
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