Trial Outcomes & Findings for Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients (NCT NCT00530920)
NCT ID: NCT00530920
Last Updated: 2014-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Baseline (Day 0) to Final (Day 14)
Results posted on
2014-06-06
Participant Flow
Participant milestones
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
28
|
|
Overall Study
COMPLETED
|
30
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
4
|
Reasons for withdrawal
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Overall Study
Randomized but not treated
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
Baseline characteristics by cohort
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=28 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 7.54 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 8.04 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 8 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 7.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=28 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
|
-1.43 Log10 copies/mL
Interval -1.66 to -1.24
|
-1.55 Log10 copies/mL
Interval -1.7 to -1.37
|
-1.47 Log10 copies/mL
Interval -1.66 to -1.09
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore "clear-ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Apparent Oral Clearance I(Cl/F) of Tipranavir
|
1.45 L/h
Geometric Coefficient of Variation 26.79
|
1.43 L/h
Geometric Coefficient of Variation 26.77
|
1.57 L/h
Geometric Coefficient of Variation 35.40
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Tipranavir (TPV) pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=29 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=22 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
|
571.3 h*uM
Geometric Coefficient of Variation 27.3
|
289.3 h*uM
Geometric Coefficient of Variation 26.8
|
538.2 h*uM
Geometric Coefficient of Variation 36.4
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
TPV pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=29 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=22 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
|
3.26 uM
Geometric Coefficient of Variation 92.4
|
10.27 uM
Geometric Coefficient of Variation 49.4
|
17.75 uM
Geometric Coefficient of Variation 71.7
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
TPV pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=29 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=22 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Trough Concentration (Cmin) of Tipranavir
|
2.8 uM
Geometric Coefficient of Variation 106.8
|
12.73 uM
Geometric Coefficient of Variation 53.1
|
21.26 uM
Geometric Coefficient of Variation 86.8
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
TPV pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=29 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=22 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Tipranavir
|
54.64 uM
Geometric Coefficient of Variation 20.2
|
36.98 uM
Geometric Coefficient of Variation 19.9
|
69.66 uM
Geometric Coefficient of Variation 26.5
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Tipranavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Volume of Distribution (V/F) of Tipranavir
|
10.02 L
Geometric Coefficient of Variation 14.33
|
9.33 L
Geometric Coefficient of Variation 9.17
|
9.39 L
Geometric Coefficient of Variation 12.34
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Tipranavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Terminal Half-Life (t1/2) of Tipranavir
|
4.79 h
Geometric Coefficient of Variation 26.3
|
4.51 h
Geometric Coefficient of Variation 22.4
|
4.14 h
Geometric Coefficient of Variation 33.6
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Tipranavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Time to Cmax (Tmax) of Tipranavir
|
3.07 h
Geometric Coefficient of Variation 14.7
|
2.34 h
Geometric Coefficient of Variation 15.2
|
2.38 h
Geometric Coefficient of Variation 16.6
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
|
5.05 h*uM
Geometric Coefficient of Variation 44.0
|
2.25 h*uM
Geometric Coefficient of Variation 47.0
|
1.74 h*uM
Geometric Coefficient of Variation 48.9
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
|
0.005 uM
Geometric Coefficient of Variation 206.2
|
0.039 uM
Geometric Coefficient of Variation 134.0
|
0.025 uM
Geometric Coefficient of Variation 129.9
|
SECONDARY outcome
Timeframe: Final (Day 13 for QD, Day 14 for BID)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Apparent Oral Clearance I(Cl/F) of Ritonavir
|
39.6 L/h
Geometric Coefficient of Variation 44.0
|
44.4 L/h
Geometric Coefficient of Variation 47.0
|
57.4 L/h
Geometric Coefficient of Variation 48.9
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Volume of Distribution (V/F) of Ritonavir
|
97.5 L
Geometric Coefficient of Variation 26.8
|
90.8 L
Geometric Coefficient of Variation 24.7
|
88.9 L
Geometric Coefficient of Variation 28.7
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Terminal Half-Life (t1/2) of Ritonavir
|
1.71 Hours
Geometric Coefficient of Variation 45.5
|
1.42 Hours
Geometric Coefficient of Variation 59.5
|
1.07 Hours
Geometric Coefficient of Variation 56.1
|
SECONDARY outcome
Timeframe: Final (Day 14)Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Tmax of Ritonavir
|
2.84 h
Geometric Coefficient of Variation 23.9
|
2.33 h
Geometric Coefficient of Variation 24.9
|
2.05 h
Geometric Coefficient of Variation 28.8
|
SECONDARY outcome
Timeframe: Visits baseline, 5, 7, 9 and 13 or 14Population: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment
Ritonavir pharmacokinetics
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Cmax of Ritonavir
|
0.632 uM
Geometric Coefficient of Variation 32.5
|
0.346 uM
Geometric Coefficient of Variation 30.7
|
0.291 uM
Geometric Coefficient of Variation 34.7
|
SECONDARY outcome
Timeframe: Screening through the end of the study (14 days)Population: Treated set.
Outcome measures
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 Participants
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 Participants
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=24 Participants
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Clinical Abnormal Findings in Laboratory and Physical Examination
Alanine aminotransferase (ALT) increased
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Abnormal Findings in Laboratory and Physical Examination
Aspartate aminotransferase (AST) increased
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 participants at risk
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 participants at risk
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=28 participants at risk
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • 14 days, from first treatment until last treatment
|
0.00%
0/25 • 14 days, from first treatment until last treatment
|
3.6%
1/28 • 14 days, from first treatment until last treatment
|
|
Investigations
Aspartate aminotransferase increaset
|
0.00%
0/30 • 14 days, from first treatment until last treatment
|
0.00%
0/25 • 14 days, from first treatment until last treatment
|
3.6%
1/28 • 14 days, from first treatment until last treatment
|
Other adverse events
| Measure |
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily
n=30 participants at risk
Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
|
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily
n=25 participants at risk
Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
|
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
n=28 participants at risk
Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
3/30 • 14 days, from first treatment until last treatment
|
4.0%
1/25 • 14 days, from first treatment until last treatment
|
3.6%
1/28 • 14 days, from first treatment until last treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
10/30 • 14 days, from first treatment until last treatment
|
12.0%
3/25 • 14 days, from first treatment until last treatment
|
39.3%
11/28 • 14 days, from first treatment until last treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/30 • 14 days, from first treatment until last treatment
|
8.0%
2/25 • 14 days, from first treatment until last treatment
|
0.00%
0/28 • 14 days, from first treatment until last treatment
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • 14 days, from first treatment until last treatment
|
4.0%
1/25 • 14 days, from first treatment until last treatment
|
14.3%
4/28 • 14 days, from first treatment until last treatment
|
|
General disorders
Fatigue
|
3.3%
1/30 • 14 days, from first treatment until last treatment
|
12.0%
3/25 • 14 days, from first treatment until last treatment
|
7.1%
2/28 • 14 days, from first treatment until last treatment
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • 14 days, from first treatment until last treatment
|
4.0%
1/25 • 14 days, from first treatment until last treatment
|
7.1%
2/28 • 14 days, from first treatment until last treatment
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • 14 days, from first treatment until last treatment
|
0.00%
0/25 • 14 days, from first treatment until last treatment
|
0.00%
0/28 • 14 days, from first treatment until last treatment
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • 14 days, from first treatment until last treatment
|
8.0%
2/25 • 14 days, from first treatment until last treatment
|
14.3%
4/28 • 14 days, from first treatment until last treatment
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • 14 days, from first treatment until last treatment
|
0.00%
0/25 • 14 days, from first treatment until last treatment
|
0.00%
0/28 • 14 days, from first treatment until last treatment
|
Additional Information
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER