Trial Outcomes & Findings for Efficacy and Safety of AQX-1125 in IC/BPS (NCT NCT01882543)

NCT ID: NCT01882543

Last Updated: 2017-09-05

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

Baseline to Week 6

Results posted on

2017-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	AQX-1125 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo 1 x placebo capsule daily Placebo: Double blind placebo capsule
Overall Study STARTED	37	32
Overall Study COMPLETED	33	29
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of AQX-1125 in IC/BPS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=99 Participants	27 Participants n=107 Participants	56 Participants n=206 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants	5 Participants n=107 Participants	13 Participants n=206 Participants
Sex/Gender, Customized Female	37 participants n=99 Participants	32 participants n=107 Participants	69 participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=99 Participants	32 Participants n=107 Participants	69 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	31 Participants n=99 Participants	30 Participants n=107 Participants	61 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment Canada	24 participants n=99 Participants	20 participants n=107 Participants	44 participants n=206 Participants
Region of Enrollment United States	13 participants n=99 Participants	12 participants n=107 Participants	25 participants n=206 Participants
Weight	67.3 kg STANDARD_DEVIATION 12.40 • n=99 Participants	76.5 kg STANDARD_DEVIATION 16.34 • n=107 Participants	71.5 kg STANDARD_DEVIATION 14.98 • n=206 Participants
BMI	26.2 kg/m^2 STANDARD_DEVIATION 4.71 • n=99 Participants	29.1 kg/m^2 STANDARD_DEVIATION 5.62 • n=107 Participants	27.5 kg/m^2 STANDARD_DEVIATION 5.31 • n=206 Participants
Duration of Diagnosis	63.5 Months STANDARD_DEVIATION 54.43 • n=99 Participants	76.3 Months STANDARD_DEVIATION 57.28 • n=107 Participants	69.4 Months STANDARD_DEVIATION 55.73 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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'.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) Baseline	6.4 units on a scale Standard Error 0.14	6.7 units on a scale Standard Error 0.18
Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) Week 6: Change from Baseline	-2.4 units on a scale Standard Error 0.37	-1.4 units on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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'.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary) Baseline	7.6 units on a scale Standard Error 0.17	7.9 units on a scale Standard Error 0.19
Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary) Week 6: Change from Baseline	-2.6 units on a scale Standard Error 0.42	-1.4 units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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'.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Change From Baseline in the Average Bladder Pain Score (Clinic) Baseline	6.7 units on a scale Standard Error 0.19	6.7 units on a scale Standard Error 0.20
Change From Baseline in the Average Bladder Pain Score (Clinic) Week 6: Change from Baseline	-2.6 units on a scale Standard Error 0.46	-1.1 units on a scale Standard Error 0.40

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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'.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Change From Baseline in the Maximum Bladder Pain Score (Clinic) Baseline	8.1 units on a scale Standard Error 0.22	8.0 units on a scale Standard Error 0.23
Change From Baseline in the Maximum Bladder Pain Score (Clinic) Week 6: Change from Baseline	-2.8 units on a scale Standard Error 0.55	-1.1 units on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS] Baseline	29.6 units on a scale Standard Error 0.59	31.6 units on a scale Standard Error 0.58
Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS] Week 6: Change from Baseline	-8.8 units on a scale Standard Error 1.37	-4.0 units on a scale Standard Error 1.17

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] Week 6: Change from Baseline (ICSI/PI)	-7.3 units on a scale Standard Error 1.25	-3.0 units on a scale Standard Error 1.04
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] Baseline (ICSI)	14.4 units on a scale Standard Error 0.48	16.1 units on a scale Standard Error 0.51
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] Baseline (ICSI/PI)	27.3 units on a scale Standard Error 0.83	30.2 units on a scale Standard Error 0.78
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] Week 6: Change from Baseline (ICSI)	-3.8 units on a scale Standard Error 0.62	-1.4 units on a scale Standard Error 0.57
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] Baseline (ICPI)	12.9 units on a scale Standard Error 0.39	14.1 units on a scale Standard Error 0.34
O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI] Week 6: Change from Baseline (ICPI)	-3.6 units on a scale Standard Error 0.69	-1.6 units on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire Baseline (Mental Component)	46.4 units on a scale Standard Error 1.34	41.3 units on a scale Standard Error 2.20
Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire Week 6: Change from Baseline (Mental Component)	0.5 units on a scale Standard Error 1.97	4.0 units on a scale Standard Error 1.67
Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire Baseline (Physical Component)	41.4 units on a scale Standard Error 1.42	36.1 units on a scale Standard Error 2.11
Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire Week 6: Change from Baseline (Physical Component)	3.8 units on a scale Standard Error 1.55	1.8 units on a scale Standard Error 1.22

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

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.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 Participants 1 x placebo capsule daily Placebo: Double blind placebo capsule
Voiding Frequency as Recorded by Diary Over a 24 Hour Period Baseline	15.7 number of voids Standard Error 1.21	16.8 number of voids Standard Error 1.26
Voiding Frequency as Recorded by Diary Over a 24 Hour Period Week 6: Change from Baseline	-3.6 number of voids Standard Error 1.05	-0.8 number of voids Standard Error 0.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 6

Population: The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.

AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6.

Outcome measures

Outcome measures
Measure	AQX-1125 n=37 Participants 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo 1 x placebo capsule daily Placebo: Double blind placebo capsule
AQX-1125 Concentrations in Plasma and Urine (Trough Values) Urine Week 6	33,396 ng/mL Standard Deviation 27,873	—
AQX-1125 Concentrations in Plasma and Urine (Trough Values) Plasma Week 4	252 ng/mL Standard Deviation 129	—
AQX-1125 Concentrations in Plasma and Urine (Trough Values) Plasma Week 6	225 ng/mL Standard Deviation 127	—
AQX-1125 Concentrations in Plasma and Urine (Trough Values) Urine Week 4	49,863 ng/mL Standard Deviation 40,630	—

Adverse Events

AQX-1125

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AQX-1125 n=37 participants at risk 1 x AQX-1125 Capsule daily AQX-1125: Synthetic SHIP1 activator	Placebo n=32 participants at risk 1 x placebo capsule daily Placebo: Double blind placebo capsule
Gastrointestinal disorders Abdominal discomfort or pain (upper/lower)	8.1% 3/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	15.6% 5/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Gastrointestinal disorders Diarrhea	10.8% 4/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	12.5% 4/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Gastrointestinal disorders Dyspepsia	5.4% 2/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	0.00% 0/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Gastrointestinal disorders Gastroesophageal reflux disease	5.4% 2/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	3.1% 1/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Gastrointestinal disorders Nausea	2.7% 1/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	9.4% 3/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Gastrointestinal disorders Vomiting	2.7% 1/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	9.4% 3/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
General disorders Edema (including peripheral)	0.00% 0/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	6.2% 2/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Infections and infestations Sinusitis + vital sinusitis	8.1% 3/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	0.00% 0/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Infections and infestations Urinary tract infection	5.4% 2/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	6.2% 2/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Investigations Increased blood pressure	0.00% 0/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	6.2% 2/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Nervous system disorders Headache	0.00% 0/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	6.2% 2/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Renal and urinary disorders Interstitial Cystitis	5.4% 2/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	6.2% 2/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.
Skin and subcutaneous tissue disorders Rash	10.8% 4/37 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.	12.5% 4/32 • Adverse events were collected from signing of informed consent until discharge from study at Week 10 Adverse events were any unfavorable medical occurrence reported by the subject during the study. In addition, abnormal findings noted during the vital signs, ECG, physical or ophthalmology examinations deemed by the Investigator to be clinically significant were captured as adverse events.

Additional Information

J. Curtis Nickel

Department of Urology, Queens University, Ontario

Phone: 613-548-2497

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 1st publication to be a joint publication within 18 months of completion or termination of the trial at all sites. If not done the PI can publish separately, pending sponsor review 60 days prior to publication. PI agrees to remove sponsor confidential info. If sponsor identifies info it wishes to obtain IP protection for, PI agrees to remove sponsor identified info, or delay publication until the sponsor obtains IP protection and 120 calendar days from 1st submission for review to sponsor.
Publication restrictions are in place

Restriction type: OTHER