Trial Outcomes & Findings for To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea. (NCT NCT02713243)
NCT ID: NCT02713243
Last Updated: 2021-01-05
Results Overview
Number of patients reported with adverse events , serious adverse events and death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
up to Day 79
Results posted on
2021-01-05
Participant Flow
In total, 20 patients were enrolled in this study and received at least one dose of LJN452 or matching placebo for 14 days in Period 1. There will be a washout period between 7 to 28 days followed by Period 2 drug if patient on LJN452 or Placebo in Period 1 they will take Placebo or LJN452 respectively in Period 2 for 14 days
Participant milestones
| Measure |
LJN452 Followed by Placebo
Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.
|
Placebo Followed by LJN452
Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
PD Analysis Set
|
9
|
10
|
|
Overall Study
PK Analysis Set
|
8
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
LJN452 Followed by Placebo
Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.
|
Placebo Followed by LJN452
Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.
|
|---|---|---|
|
Overall Study
Abnormal laboratory value(s)#
|
1
|
0
|
|
Overall Study
Administrative problems
|
0
|
1
|
|
Overall Study
Protocol deviation
|
0
|
1
|
Baseline Characteristics
To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.
Baseline characteristics by cohort
| Measure |
LJN452 Followed by Placebo
n=10 Participants
Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days.
|
Placebo Followed by LJN452
n=10 Participants
Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 13.25 • n=39 Participants
|
57.9 years
STANDARD_DEVIATION 16.47 • n=41 Participants
|
53.7 years
STANDARD_DEVIATION 15.19 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: up to Day 79Population: Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
Number of patients reported with adverse events , serious adverse events and death.
Outcome measures
| Measure |
Placebo ALL Patients
n=19 Participants
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=17 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.
AEs, Patients with AEs
|
14 count of participants
|
9 count of participants
|
|
Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.
Study drug-related AEs
|
4 count of participants
|
0 count of participants
|
|
Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.
Serious AEs
|
0 count of participants
|
0 count of participants
|
|
Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.
Death
|
0 count of participants
|
0 count of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combinedPopulation: PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data.
Stool frequency at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined
Outcome measures
| Measure |
Placebo ALL Patients
n=20 Participants
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=20 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Baseline
|
15.9 Stools per week
Standard Deviation 6.92
|
18.0 Stools per week
Standard Deviation 9.39
|
|
Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 1 (Period 1 & 2)
|
16.2 Stools per week
Standard Deviation 7.19
|
20.0 Stools per week
Standard Deviation 11.62
|
|
Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 2 (Period 1 & 2)
|
17.5 Stools per week
Standard Deviation 10.88
|
18.8 Stools per week
Standard Deviation 9.68
|
|
Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 1 & 2(Period 1 & 2)
|
16.8 Stools per week
Standard Deviation 9.11
|
19.4 Stools per week
Standard Deviation 10.56
|
PRIMARY outcome
Timeframe: Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combinedPopulation: PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data.
Stool Form at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.
Outcome measures
| Measure |
Placebo ALL Patients
n=20 Participants
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=20 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Baseline
|
5.1 score on a scale
Standard Deviation 0.94
|
5.5 score on a scale
Standard Deviation 0.87
|
|
Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 1 (Period 1 & 2)
|
5.3 score on a scale
Standard Deviation 0.79
|
5.3 score on a scale
Standard Deviation 0.78
|
|
Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 2 (Period 1 & 2)
|
5.1 score on a scale
Standard Deviation 1.01
|
4.9 score on a scale
Standard Deviation 0.82
|
|
Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 1 & 2(Period 1 & 2)
|
5.2 score on a scale
Standard Deviation 0.90
|
5.1 score on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)Population: PK analysis set: Patients with at least one valid PK concentration measurement and no major protocol deviations affecting PK No statistical Analysis
AUCtau- is the area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau \[mass x time / volume\]
Outcome measures
| Measure |
Placebo ALL Patients
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=17 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile (AUCtau) of LJN452
Day 1
|
—
|
23.6 hr*ng/mL
Standard Deviation 7.24
|
|
Area Under the Plasma Concentration-time Profile (AUCtau) of LJN452
Day 12
|
—
|
22.1 hr*ng/mL
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)Population: PK analysis set: Patients with at least one valid PK concentration measurement and no major protocol deviations affecting PK - No statistical Analysis
Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration \[mass / volume\]
Outcome measures
| Measure |
Placebo ALL Patients
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=17 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
(Cmax) of LJN452
Day 1
|
—
|
1.63 ng/mL
Standard Deviation 0.414
|
|
(Cmax) of LJN452
Day 12
|
—
|
1.82 ng/mL
Standard Deviation 0.704
|
SECONDARY outcome
Timeframe: Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)Population: PK analysis set: Patients with at least one valid PK concentration measurement and no major protocol deviations affecting PK; No statistical Analysis
Tmax is the time to reach the maximum concentration after drug administration \[time\]
Outcome measures
| Measure |
Placebo ALL Patients
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=17 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
Time to Reach Maximum Concentration After Drug Administration (Tmax)
Day 1
|
—
|
5.00 hr
Interval 3.92 to 8.0
|
|
Time to Reach Maximum Concentration After Drug Administration (Tmax)
Day 12
|
—
|
5.00 hr
Interval 1.83 to 8.0
|
SECONDARY outcome
Timeframe: Baseline, Week 1 (Period 1 & 2), Week 2 (Period 1 & 2), Week 1 & 2 combinedPopulation: Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined; Rescue Medication used was loperamide
Outcome measures
| Measure |
Placebo ALL Patients
n=20 Participants
All Patients on Placebo in both Period 1 and Period 2
|
LJN452 ALL Patients
n=20 Participants
All Patients on LJN452 in both Period 1 and Period 2
|
|---|---|---|
|
Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Baseline
|
1.3 mg
Standard Deviation 5.66
|
0.9 mg
Standard Deviation 3.50
|
|
Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 1 (Period 1 & 2)
|
0.7 mg
Standard Deviation 2.06
|
0.6 mg
Standard Deviation 1.75
|
|
Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 2 (Period 1 & 2)
|
0.7 mg
Standard Deviation 1.68
|
0.5 mg
Standard Deviation 1.37
|
|
Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Week 1 & 2(Period 1 & 2)
|
0.7 mg
Standard Deviation 1.85
|
0.6 mg
Standard Deviation 1.54
|
Adverse Events
LJN452 ALL Patients
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo ALL Patients
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LJN452 ALL Patients
n=17 participants at risk
All Patients on LJN452 in both Period 1 and Period 2
|
Placebo ALL Patients
n=19 participants at risk
All Patients on Placebo in both Period 1 and Period 2
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Anal incontinence
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Bile acid malabsorption
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
General disorders
Non-cardiac chest pain
|
11.8%
2/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Hepatobiliary disorders
Biliary dyspepsia
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Infections and infestations
Rhinitis
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
21.1%
4/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Nervous system disorders
Migraine
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
1/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
0.00%
0/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
5.3%
1/19 • Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) Day 79. All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit (Day 79).
Safety analysis set consists of 20 patients(10 pts per treatment period),17 \&19 patients received at least 1 LJN \& 1 Placebo dose, respectively, therefore 17 pts in the LJN452 \&19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER