Trial Outcomes & Findings for Tadalafil for the Treatment of Raynaud's (NCT NCT00822354)
NCT ID: NCT00822354
Last Updated: 2014-12-04
Results Overview
Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
COMPLETED
NA
10 participants
9 weeks
2014-12-04
Participant Flow
Participant milestones
| Measure |
Tadalafil Followed by Placebo
Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
|
Placebo Followed by Tadalafil
Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
|
|---|---|---|
|
First Intervention (28 Days)
STARTED
|
5
|
5
|
|
First Intervention (28 Days)
COMPLETED
|
4
|
5
|
|
First Intervention (28 Days)
NOT COMPLETED
|
1
|
0
|
|
Washout (7 Days)
STARTED
|
4
|
5
|
|
Washout (7 Days)
COMPLETED
|
4
|
5
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (28 Days)
STARTED
|
4
|
5
|
|
Second Intervention (28 Days)
COMPLETED
|
3
|
5
|
|
Second Intervention (28 Days)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tadalafil for the Treatment of Raynaud's
Baseline characteristics by cohort
| Measure |
Tadalafil Followed by Placebo
n=5 Participants
Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
|
Placebo Followed by Tadalafil
n=5 Participants
Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.
Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Outcome measures
| Measure |
Pre-treatment
n=8 Participants
|
Week 4 of Treatment
n=8 Participants
|
Pre-placebo
n=8 Participants
|
Week 4 of Placebo
n=8 Participants
|
|---|---|---|---|---|
|
Number of Raynaud's Phenomenon Attacks Per Day
|
2.4 Raynaud's attacks per day
Interval 0.2 to 8.1
|
1.1 Raynaud's attacks per day
Interval 0.1 to 6.8
|
2.0 Raynaud's attacks per day
Interval 0.3 to 6.7
|
2.3 Raynaud's attacks per day
Interval 0.5 to 6.6
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.
Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Outcome measures
| Measure |
Pre-treatment
n=8 Participants
|
Week 4 of Treatment
n=8 Participants
|
Pre-placebo
n=8 Participants
|
Week 4 of Placebo
n=8 Participants
|
|---|---|---|---|---|
|
Duration of Raynaud's Phenomenon Attacks
|
5.7 minutes
Interval 0.1 to 60.4
|
11.4 minutes
Interval 1.0 to 35.4
|
1.2 minutes
Interval 0.1 to 13.2
|
14.2 minutes
Interval 5.6 to 39.5
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.
The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Outcome measures
| Measure |
Pre-treatment
n=8 Participants
|
Week 4 of Treatment
n=8 Participants
|
Pre-placebo
n=8 Participants
|
Week 4 of Placebo
n=8 Participants
|
|---|---|---|---|---|
|
Raynaud Severity Visual Analog Score (VAS)
|
39 millimeters
Interval 19.0 to 100.0
|
16.5 millimeters
Interval 1.0 to 55.0
|
51.5 millimeters
Interval 11.0 to 71.0
|
37 millimeters
Interval 9.0 to 69.0
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.
The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Outcome measures
| Measure |
Pre-treatment
n=8 Participants
|
Week 4 of Treatment
n=8 Participants
|
Pre-placebo
n=8 Participants
|
Week 4 of Placebo
n=8 Participants
|
|---|---|---|---|---|
|
Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)
|
38.5 millimeters
Interval 7.0 to 84.0
|
9 millimeters
Interval 0.0 to 57.0
|
35 millimeters
Interval 0.0 to 60.0
|
26 millimeters
Interval 0.0 to 70.0
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 10, Week 2 data was used for Week 4 of placebo because digital blood pressure data was not obtained at the Week 4 visit.
Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Outcome measures
| Measure |
Pre-treatment
n=8 Participants
|
Week 4 of Treatment
n=8 Participants
|
Pre-placebo
n=8 Participants
|
Week 4 of Placebo
n=8 Participants
|
|---|---|---|---|---|
|
Digital Blood Pressure
|
97 mm Hg
Interval 44.0 to 127.0
|
80 mm Hg
Interval 60.0 to 127.0
|
84 mm Hg
Interval 71.0 to 121.0
|
80 mm Hg
Interval 67.0 to 121.0
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 8, Baseline/Week 0 data was used for both Pre-treatment and Pre-placebo, and Week 2 data was used for Week 4 of placebo.
Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Outcome measures
| Measure |
Pre-treatment
n=8 Participants
|
Week 4 of Treatment
n=8 Participants
|
Pre-placebo
n=8 Participants
|
Week 4 of Placebo
n=8 Participants
|
|---|---|---|---|---|
|
Capillary Diameter
|
9.3 micrometers
Interval 6.5 to 19.3
|
10 micrometers
Interval 3.6 to 19.3
|
10.7 micrometers
Interval 5.7 to 25.7
|
10 micrometers
Interval 7.9 to 17.1
|
Adverse Events
Tadalafil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place