Trial Outcomes & Findings for OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis (NCT NCT04375878)
NCT ID: NCT04375878
Last Updated: 2022-09-13
Results Overview
Number of subjects reporting 1 or more adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Each 3-week treatment period (crossover period) and 2-week treatment period (Extension period)
Results posted on
2022-09-13
Participant Flow
Patients in extension arms only included patients who were already part of the initial phase of the study.
Participant milestones
| Measure |
MS1819 (2240 mg/Day)-PERT Treatment Sequence
Patients were randomized to MS1819 (2240 mg/day) first and then PERT.
|
PERT-MS1819 (2240 mg/Day) Sequence
Patients were randomized to PERT first and then MS1819 (2240 mg/day).
|
MS1819 (4480 mg/Day)-PERT Treatment Sequence
Patients were first randomized to MS1819 (4480 mg/day) and then PERT.
|
PERT-MS1819 (4480 mg/Day) Treatment Sequence
Patients were first randomized to PERT and then MS1819 (4480 mg/day)
|
Extension MS1819 IR (4.4 g/Day)
Regardless of previous treatment sequence in study patients received MS1819 IR 4.4 g/day
|
Extension MS1819 (6.7 g/Day)
Regardless of previous treatment sequence in study patients received MS1819 IR 6.7 g/day
|
|---|---|---|---|---|---|---|
|
Crossover First and Second Interventions
STARTED
|
7
|
7
|
6
|
7
|
0
|
0
|
|
Crossover First and Second Interventions
COMPLETED
|
6
|
6
|
5
|
7
|
0
|
0
|
|
Crossover First and Second Interventions
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
0
|
9
|
8
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
8
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
MS1819 (2240 mg/Day)-PERT Treatment Sequence
Patients were randomized to MS1819 (2240 mg/day) first and then PERT.
|
PERT-MS1819 (2240 mg/Day) Sequence
Patients were randomized to PERT first and then MS1819 (2240 mg/day).
|
MS1819 (4480 mg/Day)-PERT Treatment Sequence
Patients were first randomized to MS1819 (4480 mg/day) and then PERT.
|
PERT-MS1819 (4480 mg/Day) Treatment Sequence
Patients were first randomized to PERT and then MS1819 (4480 mg/day)
|
Extension MS1819 IR (4.4 g/Day)
Regardless of previous treatment sequence in study patients received MS1819 IR 4.4 g/day
|
Extension MS1819 (6.7 g/Day)
Regardless of previous treatment sequence in study patients received MS1819 IR 6.7 g/day
|
|---|---|---|---|---|---|---|
|
Crossover First and Second Interventions
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Crossover First and Second Interventions
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Extension Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
MS1819 (2240 mg/Day)-PERT Treatment Sequence
n=6 Participants
Patients were randomized to MS1819 (2240 mg/day) first and then PERT.
|
PERT-MS1819 (2240 mg/Day) Sequence
n=7 Participants
Patients were randomized to PERT first and then MS1819 (2240 mg/day).
|
MS1819 (4480 mg/Day)-PERT Treatment Sequence
n=5 Participants
Patients were first randomized to MS1819 (4480 mg/day) and then PERT.
|
PERT-MS1819 (4480 mg/Day) Treatment Sequence
n=7 Participants
Patients were first randomized to PERT and then MS1819 (4480 mg/day)
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
25.2 Years
STANDARD_DEVIATION 6.5 • n=93 Participants
|
27.7 Years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
27.4 Years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
29.3 Years
STANDARD_DEVIATION 4.3 • n=483 Participants
|
27.3 Years
STANDARD_DEVIATION 1.8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Each 3-week treatment period (crossover period) and 2-week treatment period (Extension period)Population: Safety Population
Number of subjects reporting 1 or more adverse events
Outcome measures
| Measure |
MS1819 (2240 mg/Day)
n=14 Participants
Patients were randomized to MS1819 (2240 mg/day) first and then PERT or PERT and then MS1819 (2240 mg/day)
|
PERT ( MS1819 2240 mg/Day Crossover Group)
n=13 Participants
Patients on PERT in MS1819 (2240 mg/day) - PERT or PERT-MS1819 (2240 mg/day) treatment sequences.
|
MS1819 (4480 mg/Day)
n=13 Participants
Patients were first randomized to MS1819 (4480 mg/day) and then PERT or or PERT and then MS1819 (4480 mg/day)
|
PERT (MS1819 4480 mg/Day Crossover Group)
n=12 Participants
Patients on PERT in MS1819 (4480 mg/day) - PERT or PERT-MS1819 (44800 mg/day) treatment sequences.
|
Extension MS1819 IR (4.4 g/Day)
n=9 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 4.4 g/day
|
Extension MS1819 (6.7 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 6.7 g/day
|
|---|---|---|---|---|---|---|
|
Safety of MS1819 by Number of Subjects Reporting 1 or More Adverse Events
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 weeks for crossover phase (to complete both first and second intervention) and 2 weeks for extension phase.Population: Modified intent to treat
The primary efficacy endpoint is the CFA that will be assessed at the end of each 3-week treatment period (crossover period) and 2-week treatment period (Extension period). CFAs for MS1819 will be compared to the CFAs of PERT using descriptive methods.
Outcome measures
| Measure |
MS1819 (2240 mg/Day)
n=12 Participants
Patients were randomized to MS1819 (2240 mg/day) first and then PERT or PERT and then MS1819 (2240 mg/day)
|
PERT ( MS1819 2240 mg/Day Crossover Group)
n=12 Participants
Patients on PERT in MS1819 (2240 mg/day) - PERT or PERT-MS1819 (2240 mg/day) treatment sequences.
|
MS1819 (4480 mg/Day)
n=12 Participants
Patients were first randomized to MS1819 (4480 mg/day) and then PERT or or PERT and then MS1819 (4480 mg/day)
|
PERT (MS1819 4480 mg/Day Crossover Group)
n=11 Participants
Patients on PERT in MS1819 (4480 mg/day) - PERT or PERT-MS1819 (44800 mg/day) treatment sequences.
|
Extension MS1819 IR (4.4 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 4.4 g/day
|
Extension MS1819 (6.7 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 6.7 g/day
|
|---|---|---|---|---|---|---|
|
Efficacy of MS1819: Coefficient of Fat Absorption (CFA)
|
66 percentage of fat absorption
Standard Deviation 19.1
|
83.3 percentage of fat absorption
Standard Deviation 13.1
|
52.8 percentage of fat absorption
Standard Deviation 19.4
|
89.3 percentage of fat absorption
Standard Deviation 4.7
|
52.9 percentage of fat absorption
Standard Deviation 12.3
|
50.6 percentage of fat absorption
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Each 3-week treatment period (crossover period) and 2-week treatment period (Extension period)Population: modified intent to treat
The relative efficacy of MS1819 compared to porcine PERT will be assessed using stool weights.
Outcome measures
| Measure |
MS1819 (2240 mg/Day)
n=12 Participants
Patients were randomized to MS1819 (2240 mg/day) first and then PERT or PERT and then MS1819 (2240 mg/day)
|
PERT ( MS1819 2240 mg/Day Crossover Group)
n=12 Participants
Patients on PERT in MS1819 (2240 mg/day) - PERT or PERT-MS1819 (2240 mg/day) treatment sequences.
|
MS1819 (4480 mg/Day)
n=12 Participants
Patients were first randomized to MS1819 (4480 mg/day) and then PERT or or PERT and then MS1819 (4480 mg/day)
|
PERT (MS1819 4480 mg/Day Crossover Group)
n=11 Participants
Patients on PERT in MS1819 (4480 mg/day) - PERT or PERT-MS1819 (44800 mg/day) treatment sequences.
|
Extension MS1819 IR (4.4 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 4.4 g/day
|
Extension MS1819 (6.7 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 6.7 g/day
|
|---|---|---|---|---|---|---|
|
Stool Weights
|
1086.9 grams
Standard Deviation 609.2
|
664.4 grams
Standard Deviation 361.1
|
1689.6 grams
Standard Deviation 681.8
|
644.7 grams
Standard Deviation 310.1
|
1301.6 grams
Standard Deviation 478.7
|
1409.3 grams
Standard Deviation 448.0
|
SECONDARY outcome
Timeframe: Each 3-week treatment period (crossover period) and 2-week treatment period (Extension period)Population: modified intent to treat
CNA that will be assessed at the end of each 3-week treatment period (crossover period) and 2-week treatment period (Extension period). CFAs for MS1819 will be compared to the CFAs of PERT using descriptive methods. CNAs for MS1819 will be compared to the CNAs of PERT using descriptive methods.
Outcome measures
| Measure |
MS1819 (2240 mg/Day)
n=12 Participants
Patients were randomized to MS1819 (2240 mg/day) first and then PERT or PERT and then MS1819 (2240 mg/day)
|
PERT ( MS1819 2240 mg/Day Crossover Group)
n=12 Participants
Patients on PERT in MS1819 (2240 mg/day) - PERT or PERT-MS1819 (2240 mg/day) treatment sequences.
|
MS1819 (4480 mg/Day)
n=12 Participants
Patients were first randomized to MS1819 (4480 mg/day) and then PERT or or PERT and then MS1819 (4480 mg/day)
|
PERT (MS1819 4480 mg/Day Crossover Group)
n=11 Participants
Patients on PERT in MS1819 (4480 mg/day) - PERT or PERT-MS1819 (44800 mg/day) treatment sequences.
|
Extension MS1819 IR (4.4 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 4.4 g/day
|
Extension MS1819 (6.7 g/Day)
n=8 Participants
Regardless of previous treatment sequence in study patients received MS1819 IR 6.7 g/day
|
|---|---|---|---|---|---|---|
|
Coefficient of Nitrogen Absorption (CNA)
|
94.4 percentage of nitrogen absorption
Standard Deviation 3.3
|
97.3 percentage of nitrogen absorption
Standard Deviation 1.8
|
90.9 percentage of nitrogen absorption
Standard Deviation 3.9
|
97.5 percentage of nitrogen absorption
Standard Deviation 1.0
|
93.1 percentage of nitrogen absorption
Standard Deviation 2.4
|
92.6 percentage of nitrogen absorption
Standard Deviation 2.5
|
Adverse Events
MS1819 (2240 mg/Day)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PERT (MS1819 2240 mg/Day Crossover Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MS1819 (4480 mg/Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PERT (MS1819 4480 mg/Day Crossover Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extension MS1819 IR (4.4 g/Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Extension MS1819 IR (6.7g/Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MS1819 (2240 mg/Day)
n=14 participants at risk
Patients on MS1819 in MS1819 (2240 mg/day) - PERT or PERT-MS1819 (2240 mg/day) treatment sequences.
|
PERT (MS1819 2240 mg/Day Crossover Group)
n=13 participants at risk
Patients on PERT in MS1819 (2240 mg/day) - PERT or PERT-MS1819 (2240 mg/day) treatment sequences.
|
MS1819 (4480 mg/Day)
n=13 participants at risk
Patients on MS1819 in MS1819 (4480 mg/day) - PERT or PERT-MS1819 (4480 mg/day) treatment sequences.
|
PERT (MS1819 4480 mg/Day Crossover Group
n=12 participants at risk
Patients on PERT in MS1819 (4480 mg/day) - PERT or PERT-MS1819 (4480 mg/day) treatment sequences.
|
Extension MS1819 IR (4.4 g/Day)
n=9 participants at risk
Patients enrolled in crossover phase
|
Extension MS1819 IR (6.7g/Day)
n=8 participants at risk
Patients enrolled in crossover phase
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Viral Infection
|
7.1%
1/14 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/8 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
7.7%
1/13 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/8 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
11.1%
1/9 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
7.7%
1/13 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/8 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
7.7%
1/13 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/8 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
7.7%
1/13 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/8 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
11.1%
1/9 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
11.1%
1/9 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/8 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
General disorders
Thirst
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/13 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/12 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
0.00%
0/9 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
12.5%
1/8 • Number of events 1 • Up to 15 weeks. The maximum overall duration for patients who participated in the crossover phase and extension phase, including screening and end of study visit was 15 weeks. The maximum overall duration for patients who participated in the crossover phase but did not participate in the extension phase, including screening and end of study visit was 11 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place