Trial Outcomes & Findings for A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) (NCT NCT00788593)

Last Updated: 2014-03-12

Results Overview

Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

82 participants

Primary outcome timeframe

3 to 5 days of hospital treatment in first and second intervention periods

Results posted on

2014-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Baseline Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).	EUR-1008 (APT-1008) High Dose, Then Low Dose EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.	EUR-1008 (APT-1008) Low Dose, Then High Dose EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
Placebo Run-in Phase STARTED	82	0	0
Placebo Run-in Phase COMPLETED	76	0	0
Placebo Run-in Phase NOT COMPLETED	6	0	0
First Intervention Period STARTED	0	39	37
First Intervention Period COMPLETED	0	38	37
First Intervention Period NOT COMPLETED	0	1	0
Second Intervention Period STARTED	0	38	37
Second Intervention Period COMPLETED	0	37	36
Second Intervention Period NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Baseline Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).	EUR-1008 (APT-1008) High Dose, Then Low Dose EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.	EUR-1008 (APT-1008) Low Dose, Then High Dose EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
Placebo Run-in Phase Adverse Event	2	0	0
Placebo Run-in Phase Withdrawal by Subject	2	0	0
Placebo Run-in Phase Protocol Violation	2	0	0
First Intervention Period Adverse Event	0	1	0
Second Intervention Period Lost to Follow-up	0	1	0
Second Intervention Period Other	0	0	1

Baseline Characteristics

A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=82 Participants Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
Age, Continuous	51.91 years STANDARD_DEVIATION 12.08 • n=99 Participants
Sex: Female, Male Female	29 Participants n=99 Participants
Sex: Female, Male Male	53 Participants n=99 Participants
Body Weight	68.75 kilogram (kg) STANDARD_DEVIATION 14.12 • n=99 Participants
Body Mass Index (BMI)	23.36 kg/m^2 STANDARD_DEVIATION 4.44 • n=99 Participants

PRIMARY outcome

Timeframe: 3 to 5 days of hospital treatment in first and second intervention periods

Population: FAS included all participants who received at least 1 dose of the study medication. Here "N" (number of participants analyzed) signifies those participants for whom the CFA values were available.

Outcome measures

Outcome measures
Measure	EUR-1008 (APT-1008) Low Dose n=72 Participants EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=72 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008	88.87 percent CFA Standard Deviation 12.44	89.86 percent CFA Standard Deviation 8.77 • Interval -0.656 to 2.701	—

SECONDARY outcome

Timeframe: Baseline, 3 to 5 days of hospital treatment in first and second intervention periods

Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.

Outcome measures

Outcome measures
Measure	EUR-1008 (APT-1008) Low Dose n=82 Participants EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=72 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=72 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment Baseline	81.68 percent CFA Standard Deviation 22.13	NA percent CFA Standard Deviation NA Data was not reported as EUR-1008 low dose was not given at baseline.	NA percent CFA Standard Deviation NA Data was not reported as EUR-1008 high dose was not given at baseline.
Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment Change During Hospital Period	NA percent CFA Standard Deviation NA Data was not reported as placebo was not given during hospital treatment period.	7.19 percent CFA Standard Deviation 14.49	8.18 percent CFA Standard Deviation 17.35

SECONDARY outcome

Timeframe: Baseline, 3 to 5 days of hospital treatment in first and second intervention periods

Population: FAS included all participants who received at least one dose of the study drug. Here "N" (number of participants analyzed) represents number of participants who were evaluable for this outcome measure.

Percent CNA was calculated as \[(nitrogen intake - nitrogen excretion)/nitrogen intake\]\*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.

Outcome measures

Outcome measures
Measure	EUR-1008 (APT-1008) Low Dose n=82 Participants EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=74 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=75 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment Baseline	78.05 percent CNA Standard Deviation 18.64	NA percent CNA Standard Deviation NA Data was not reported as EUR-1008 low dose was not given at baseline.	NA percent CNA Standard Deviation NA Data was not reported as EUR-1008 high dose was not given at baseline.
Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment Change During Hospital Period	NA percent CNA Standard Deviation NA Data was not reported as placebo was not given during hospital treatment period.	5.33 percent CNA Standard Deviation 10.38	7.62 percent CNA Standard Deviation 15.55

SECONDARY outcome

Timeframe: Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)

Population: FAS included all participants who received at least one dose of the study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.

Outcome measures

Outcome measures
Measure	EUR-1008 (APT-1008) Low Dose n=74 Participants EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=75 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Change From Placebo Baseline in Weight at End of Each Treatment Period	0.38 kilogram (kg) Standard Deviation 1.18	0.50 kilogram (kg) Standard Deviation 1.31	—

SECONDARY outcome

Timeframe: Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)

Population: FAS included all participants who received at least one dose of the study medication. Here "N" (number of participants analyzed) represents number of participants who were evaluable for this outcome measure.

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.

Outcome measures

Outcome measures
Measure	EUR-1008 (APT-1008) Low Dose n=74 Participants EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=75 Participants EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment	0.13 kg/m^2 Standard Deviation 0.39	0.16 kg/m^2 Standard Deviation 0.42	—

Adverse Events

Placebo Baseline

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

EUR-1008 (APT-1008) Low Dose

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

EUR-1008 (APT-1008) High Dose

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Baseline n=82 participants at risk Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).	EUR-1008 (APT-1008) Low Dose n=74 participants at risk EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.	EUR-1008 (APT-1008) High Dose n=75 participants at risk EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.4% 1/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Gastrointestinal disorders Obstruction gastric	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.3% 1/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Gastrointestinal disorders Pancreatic pseudocyst	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.3% 1/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
General disorders Pyrexia	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.4% 1/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.3% 1/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Injury, poisoning and procedural complications Renal injury	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.3% 1/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Injury, poisoning and procedural complications Wrist fracture	1.2% 1/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Nervous system disorders Cognitive disorder	0.00% 0/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	1.3% 1/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
Renal and urinary disorders Nephrolithiasis	1.2% 1/82 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/74 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.	0.00% 0/75 • Baseline up to final follow-up visit (14 days after end of study) Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.

Other adverse events

Additional Information

Robert Winkler, MD, VP, Clinical Development and Operations

Aptalis Pharma US, Inc.

Phone: 1-800-472-2634

Results disclosure agreements

Principal investigator is a sponsor employee Restrictions vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.
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Restriction type: OTHER