Trial Outcomes & Findings for A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination (NCT NCT02606877)
NCT ID: NCT02606877
Last Updated: 2019-03-04
Results Overview
AUC0-tz , area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable concentration. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
Results posted on
2019-03-04
Participant Flow
This was an open-label, multiple-dose, 2-group trial in patients with idiopathic pulmonary fibrosis (IPF) to investigate the relative bioavailability of nintedanib and pirfenidone when administered alone and after coadministration.
Each patient group was treated according to a fixed sequence design, first with single treatment (R1, R2 respectively) followed by a combined treatment (T1, T2 respectively) which also included an up-titration period. Therefore, generating individual participant flow for each treatment group was not planned in this trial.
Participant milestones
| Measure |
Treatment naïve
A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
|
Pirfenidone-treated
Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Treatment naïve
A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
|
Pirfenidone-treated
Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Non-compliance with protocol
|
0
|
1
|
|
Overall Study
Other than listed above
|
1
|
0
|
Baseline Characteristics
A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination
Baseline characteristics by cohort
| Measure |
Treatment naïve
n=20 Participants
A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
|
Pirfenidone-treated
n=17 Participants
Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 Years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
68.3 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
70.0 Years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.Population: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)
AUC0-tz , area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable concentration. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Outcome measures
| Measure |
Nintedanib + Pirfenidone (T1)
n=12 Participants
A single dose of 150 mg nintedanib in combination with 801 mg tid pirfenidone (T1) at day 23.
|
Nintedanib (R1)
n=17 Participants
A single dose of 150 mg nintedanib soft gelatin capsules was administered alone (R1) at day 1.
|
|---|---|---|
|
Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
|
150.31 nanogram*hour/mililitre [ng*h/mL]
Standard Error 1.18
|
169.69 nanogram*hour/mililitre [ng*h/mL]
Standard Error 1.15
|
PRIMARY outcome
Timeframe: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.Population: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)
Cmax, maximum measured concentration of nintedanib in plasma. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Outcome measures
| Measure |
Nintedanib + Pirfenidone (T1)
n=12 Participants
A single dose of 150 mg nintedanib in combination with 801 mg tid pirfenidone (T1) at day 23.
|
Nintedanib (R1)
n=17 Participants
A single dose of 150 mg nintedanib soft gelatin capsules was administered alone (R1) at day 1.
|
|---|---|---|
|
Treatment naïve, Maximum Measured Concentration of Nintedanib in Plasma After Single Dose Administration (Cmax).
|
23.04 nanogram/mililitre [ng/mL]
Standard Error 1.23
|
28.58 nanogram/mililitre [ng/mL]
Standard Error 1.19
|
PRIMARY outcome
Timeframe: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.Population: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)
AUCτ,ss, area under the concentration-time curve of pirfenidone in plasma over a dosing interval at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Outcome measures
| Measure |
Nintedanib + Pirfenidone (T1)
n=13 Participants
A single dose of 150 mg nintedanib in combination with 801 mg tid pirfenidone (T1) at day 23.
|
Nintedanib (R1)
n=15 Participants
A single dose of 150 mg nintedanib soft gelatin capsules was administered alone (R1) at day 1.
|
|---|---|---|
|
Pirfenidone-treated, Area Under the Concentration-time Curve of Pirfenidone in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)
|
39040.84 nanogram*hour/mililitre [ng*h/mL]
Standard Error 1.07
|
40178.46 nanogram*hour/mililitre [ng*h/mL]
Standard Error 1.07
|
PRIMARY outcome
Timeframe: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.Population: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)
Cmax,ss, maximum measured concentration of pirfenidone in plasma at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Outcome measures
| Measure |
Nintedanib + Pirfenidone (T1)
n=13 Participants
A single dose of 150 mg nintedanib in combination with 801 mg tid pirfenidone (T1) at day 23.
|
Nintedanib (R1)
n=15 Participants
A single dose of 150 mg nintedanib soft gelatin capsules was administered alone (R1) at day 1.
|
|---|---|---|
|
Pirfenidone-treated, Maximum Measured Concentration of Pirfenidone in Plasma at Steady State (Cmax,ss)
|
10537.26 nanogram/mililitre [ng/mL]
Standard Error 1.08
|
10591.08 nanogram/mililitre [ng/mL]
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.Population: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)
AUC0-∞, area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Outcome measures
| Measure |
Nintedanib + Pirfenidone (T1)
n=12 Participants
A single dose of 150 mg nintedanib in combination with 801 mg tid pirfenidone (T1) at day 23.
|
Nintedanib (R1)
n=17 Participants
A single dose of 150 mg nintedanib soft gelatin capsules was administered alone (R1) at day 1.
|
|---|---|---|
|
Treatment naïve, Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
175.04 nanogram*hour/mililitre [ng*h/mL]
Standard Error 1.18
|
195.59 nanogram*hour/mililitre [ng*h/mL]
Standard Error 1.15
|
Adverse Events
Treatment naïve
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Pirfenidone-treated
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment naïve
n=20 participants at risk
A single dose of 150 mg nintedanib (R1) was administered alone and, after pirfenidone up-titration, single dose of 150mg in combination with 801 mg tid pirfenidone (T1). Patients administered capsules orally with food.
|
Pirfenidone-treated
n=17 participants at risk
Pirfenidone (R2) 801 mg tid was administered alone for 7 days as well as in combination with 150 mg bid nintedanib for another 7 days (T2). Patients administered capsules orally with food.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Abdominal wall mass
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
6/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
23.5%
4/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
0.00%
0/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
0.00%
0/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
17.6%
3/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
11.8%
2/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
General disorders
Fatigue
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
0.00%
0/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
35.3%
6/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
11.8%
2/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Investigations
Blood pressure increased
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
0.00%
0/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
23.5%
4/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
11.8%
2/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
5.9%
1/17 • From first drug administration until 28 days after last drug administration, up to 6 weeks.
The assessment of safety was a further objective of the trial. Due to the study design, there was a great difference in duration of treatment reference (R) and treatment (T) within each patient group and a long residual effect period of the first treatment that overlapped with the second treatment. Thus the study design did not allow for a reliable comparison of treatment R and T within each patient group regarding safety and the trial team decided to provide the safety assessment only overall.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER