Trial Outcomes & Findings for Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate (NCT NCT00577720)
NCT ID: NCT00577720
Last Updated: 2012-01-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
Baseline and Week 13
Results posted on
2012-01-13
Participant Flow
Screening began 14-Jul-2006
Participant milestones
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
36
|
72
|
|
Overall Study
ITT (Intent to Treat) Population
|
34
|
35
|
35
|
65
|
|
Overall Study
COMPLETED
|
33
|
35
|
35
|
65
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
7
|
Reasons for withdrawal
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
Baseline Characteristics
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Baseline characteristics by cohort
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
n=37 Participants
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
n=36 Participants
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
n=36 Participants
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
n=72 Participants
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
61.1 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian (Oriental)
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
36 participants
n=5 Participants
|
72 participants
n=4 Participants
|
181 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 13Population: ITT Population
Outcome measures
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
n=34 Participants
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
n=35 Participants
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
n=35 Participants
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
n=65 Participants
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
|
-43.20 Percent Change
Interval -55.83 to -30.58
|
-62.08 Percent Change
Interval -73.59 to -50.56
|
-65.11 Percent Change
Interval -77.7 to -52.52
|
-66.30 Percent Change
Interval -77.42 to -55.18
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT Population
Outcome measures
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
n=34 Participants
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
n=35 Participants
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
n=35 Participants
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
n=65 Participants
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population
|
-38.57 Percent Change
Interval -56.6 to -20.54
|
-46.60 Percent Change
Interval -63.04 to -30.17
|
-43.65 Percent Change
Interval -61.62 to -25.67
|
-54.27 Percent Change
Interval -70.14 to -38.4
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT Population
Outcome measures
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
n=34 Participants
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
n=35 Participants
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
n=35 Participants
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
n=65 Participants
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
|
-10.99 Percent Change
Interval -19.62 to -2.365
|
-10.41 Percent Change
Interval -18.28 to -2.545
|
-20.00 Percent Change
Interval -28.6 to -11.4
|
-17.36 Percent Change
Interval -24.96 to -9.767
|
Adverse Events
35 mg IRBB (Immediate Release Before Breakfast)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
35 mg DRFB (Delayed Release Following Breakfast)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
50 mg DRFB
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
50 mg DRBB (Delayed Release Before Breakfast)
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
n=37 participants at risk
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
n=36 participants at risk
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
n=36 participants at risk
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
n=72 participants at risk
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
General disorders
Chest Pain
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
Other adverse events
| Measure |
35 mg IRBB (Immediate Release Before Breakfast)
n=37 participants at risk
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
35 mg DRFB (Delayed Release Following Breakfast)
n=36 participants at risk
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRFB
n=36 participants at risk
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
|
50 mg DRBB (Delayed Release Before Breakfast)
n=72 participants at risk
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.1%
3/37 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
11.1%
4/36 • Number of events 4 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
4.2%
3/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.4%
2/37 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
4.2%
3/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
4.2%
3/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
6.9%
5/72 • Number of events 7 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.7%
1/37 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
4.2%
3/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
8.3%
3/36 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
11.1%
8/72 • Number of events 11 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 4 • 14 Jul 2006 thru 27 Jan 2007
|
8.3%
6/72 • Number of events 9 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Dyspepsia
|
10.8%
4/37 • Number of events 4 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
4/72 • Number of events 4 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Eructation
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Nausea
|
8.1%
3/37 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
11.1%
4/36 • Number of events 4 • 14 Jul 2006 thru 27 Jan 2007
|
12.5%
9/72 • Number of events 13 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
8.3%
3/36 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Toothache
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
16.7%
6/36 • Number of events 6 • 14 Jul 2006 thru 27 Jan 2007
|
9.7%
7/72 • Number of events 14 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 5 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
5.6%
2/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 4 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Nervous system disorders
Headache
|
18.9%
7/37 • Number of events 9 • 14 Jul 2006 thru 27 Jan 2007
|
22.2%
8/36 • Number of events 11 • 14 Jul 2006 thru 27 Jan 2007
|
27.8%
10/36 • Number of events 10 • 14 Jul 2006 thru 27 Jan 2007
|
22.2%
16/72 • Number of events 26 • 14 Jul 2006 thru 27 Jan 2007
|
|
Nervous system disorders
Sinus Headache
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Nervous system disorders
Somnolence
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 10 • 14 Jul 2006 thru 27 Jan 2007
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.1%
3/37 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Gingival Abscess
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Bronchitis
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Infections and infestations
Viral Infection
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
General disorders
Asthenia
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 3 • 14 Jul 2006 thru 27 Jan 2007
|
|
General disorders
Pain
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Investigations
Blood Glucose Increased
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Investigations
Blood Cholesterol Increased
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
1/36 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Investigations
Blood Triglycerides Increased
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
1.4%
1/72 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
1/37 • Number of events 1 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/72 • 14 Jul 2006 thru 27 Jan 2007
|
|
Vascular disorders
Hypertension
|
0.00%
0/37 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
0.00%
0/36 • 14 Jul 2006 thru 27 Jan 2007
|
2.8%
2/72 • Number of events 2 • 14 Jul 2006 thru 27 Jan 2007
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60