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Trial record 56 of 101 for:    Risedronate

Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00577720
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Postmenopausal Women
Intervention Drug: risedronate
Enrollment 181
Recruitment Details Screening began 14-Jul-2006
Pre-assignment Details  
Arm/Group Title 35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Hide Arm/Group Description 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Period Title: Overall Study
Started 37 36 36 72
ITT (Intent to Treat) Population 34 35 35 65
Completed 33 35 35 65
Not Completed 4 1 1 7
Reason Not Completed
Adverse Event             2             1             0             4
Lost to Follow-up             0             0             1             0
Protocol Violation             0             0             0             1
Withdrawal by Subject             2             0             0             2
Arm/Group Title 35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast) Total
Hide Arm/Group Description 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks Total of all reporting groups
Overall Number of Baseline Participants 37 36 36 72 181
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 36 participants 36 participants 72 participants 181 participants
61.1  (6.2) 58.9  (6.7) 60.0  (6.1) 59.7  (7.8) 59.9  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 36 participants 72 participants 181 participants
Female
37
 100.0%
36
 100.0%
36
 100.0%
72
 100.0%
181
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 36 participants 72 participants 181 participants
Hispanic or Latino
13
  35.1%
9
  25.0%
14
  38.9%
23
  31.9%
59
  32.6%
Not Hispanic or Latino
24
  64.9%
27
  75.0%
22
  61.1%
49
  68.1%
122
  67.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 36 participants 72 participants 181 participants
Asian (Oriental) 6 6 3 10 25
Black 0 1 3 2 6
Caucasian 30 29 26 56 141
Multi-Racial 0 0 0 1 1
Other 1 0 4 2 7
Hawaiian/Pacific Islander 0 0 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 36 participants 36 participants 72 participants 181 participants
37 36 36 72 181
1.Primary Outcome
Title Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
Hide Description [Not Specified]
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Hide Arm/Group Description:
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Overall Number of Participants Analyzed 34 35 35 65
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-43.20
(-55.83 to -30.58)
-62.08
(-73.59 to -50.56)
-65.11
(-77.70 to -52.52)
-66.30
(-77.42 to -55.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 35 mg DRFB (Delayed Release Following Breakfast)
Comments For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 35 mg DRFB/35 mg IRBB)
Estimated Value 1.437
Confidence Interval (2-Sided) 90%
1.091 to 1.964
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRBB (Delayed Release Before Breakfast)
Comments For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRBB/35 mg IRBB)
Estimated Value 1.507
Confidence Interval (2-Sided) 90%
1.139 to 2.066
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRFB
Comments For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/35 mg IRBB)
Estimated Value 1.535
Confidence Interval (2-Sided) 90%
1.177 to 2.086
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 35 mg DRFB (Delayed Release Following Breakfast), 50 mg DRFB
Comments For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/50 mg DRBB)
Estimated Value 1.068
Confidence Interval (2-Sided) 90%
0.867 to 1.321
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 50 mg DRFB, 50 mg DRBB (Delayed Release Before Breakfast)
Comments For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/50 mg DRBB)
Estimated Value 1.018
Confidence Interval (2-Sided) 90%
0.824 to 1.267
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Hide Arm/Group Description:
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Overall Number of Participants Analyzed 34 35 35 65
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-38.57
(-56.60 to -20.54)
-46.60
(-63.04 to -30.17)
-43.65
(-61.62 to -25.67)
-54.27
(-70.14 to -38.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 35 mg DRFB (Delayed Release Following Breakfast)
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 35 mg DRFB/35 mg IRBB)
Estimated Value 1.208
Confidence Interval (2-Sided) 90%
0.749 to 2.099
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRBB (Delayed Release Before Breakfast)
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRBB/35 mg IRBB)
Estimated Value 1.132
Confidence Interval (2-Sided) 90%
0.665 to 2.003
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRFB
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/35 mg IRBB)
Estimated Value 1.407
Confidence Interval (2-Sided) 90%
0.913 to 2.404
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 35 mg DRFB (Delayed Release Following Breakfast), 50 mg DRFB
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/35 mg DRFB)
Estimated Value 1.165
Confidence Interval (2-Sided) 90%
0.797 to 1.752
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 50 mg DRFB, 50 mg DRBB (Delayed Release Before Breakfast)
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/50 mg DRBB)
Estimated Value 1.243
Confidence Interval (2-Sided) 90%
0.828 to 1.990
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Hide Arm/Group Description:
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Overall Number of Participants Analyzed 34 35 35 65
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-10.99
(-19.62 to -2.365)
-10.41
(-18.28 to -2.545)
-20.00
(-28.60 to -11.40)
-17.36
(-24.96 to -9.767)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 35 mg DRFB (Delayed Release Following Breakfast)
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 35 mg DRFB/35 mg IRBB)
Estimated Value 0.947
Confidence Interval (2-Sided) 90%
0.316 to 2.993
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRBB (Delayed Release Before Breakfast)
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRBB/35 mg IRBB)
Estimated Value 1.820
Confidence Interval (2-Sided) 90%
0.929 to 5.429
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRFB
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/35 mg IRBB)
Estimated Value 1.580
Confidence Interval (2-Sided) 90%
0.801 to 4.718
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 35 mg DRFB (Delayed Release Following Breakfast), 50 mg DRFB
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/35 mg DRFB)
Estimated Value 1.668
Confidence Interval (2-Sided) 90%
0.856 to 4.668
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 50 mg DRFB, 50 mg DRBB (Delayed Release Before Breakfast)
Comments The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (LS Mean 50 mg DRFB/50 mgDRBB)
Estimated Value 0.868
Confidence Interval (2-Sided) 90%
0.504 to 1.488
Estimation Comments [Not Specified]
Time Frame 14 Jul 2006 thru 27 Jan 2007
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Hide Arm/Group Description 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
All-Cause Mortality
35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      1/36 (2.78%)      0/36 (0.00%)      1/72 (1.39%)    
General disorders         
Chest Pain  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Hepatobiliary disorders         
Cholelithiasis  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Infections and infestations         
Appendicitis  1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/72 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
35 mg IRBB (Immediate Release Before Breakfast) 35 mg DRFB (Delayed Release Following Breakfast) 50 mg DRFB 50 mg DRBB (Delayed Release Before Breakfast)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/37 (72.97%)      19/36 (52.78%)      24/36 (66.67%)      51/72 (70.83%)    
Cardiac disorders         
Ventricular Extrasystoles  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Ear and labyrinth disorders         
Ear Pain  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  2
Vertigo  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Eye disorders         
Conjunctival Haemorrhage  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Gastrointestinal disorders         
Abdominal Pain Upper  1  0/37 (0.00%)  0 3/36 (8.33%)  3 1/36 (2.78%)  1 8/72 (11.11%)  11
Abdominal Pain  1  1/37 (2.70%)  1 2/36 (5.56%)  2 2/36 (5.56%)  4 6/72 (8.33%)  9
Abdominal Tenderness  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Dyspepsia  1  4/37 (10.81%)  4 2/36 (5.56%)  3 0/36 (0.00%)  0 4/72 (5.56%)  4
Eructation  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Nausea  1  3/37 (8.11%)  3 2/36 (5.56%)  2 4/36 (11.11%)  4 9/72 (12.50%)  13
Vomiting  1  2/37 (5.41%)  2 1/36 (2.78%)  1 3/36 (8.33%)  3 2/72 (2.78%)  2
Toothache  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  2
Diarrhoea  1  1/37 (2.70%)  1 0/36 (0.00%)  0 6/36 (16.67%)  6 7/72 (9.72%)  14
Abdominal Distension  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Flatulence  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  5
Constipation  1  1/37 (2.70%)  1 0/36 (0.00%)  0 2/36 (5.56%)  2 2/72 (2.78%)  2
Gastrooesophageal Reflux Disease  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Stomach Discomfort  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 1/72 (1.39%)  4
Rectal Haemorrhage  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Haematochezia  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
General disorders         
Asthenia  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Fatigue  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  3
Pain  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  2
Infections and infestations         
Gastroenteritis  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  2
Herpes Zoster  1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/72 (0.00%)  0
Herpes Simplex  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Nasopharyngitis  1  1/37 (2.70%)  1 1/36 (2.78%)  1 0/36 (0.00%)  0 2/72 (2.78%)  3
Sinusitis  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Upper Respiratory Tract Infection  1  3/37 (8.11%)  3 0/36 (0.00%)  0 1/36 (2.78%)  1 2/72 (2.78%)  3
Gingival Abscess  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Fungal Skin Infection  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Bronchitis  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Viral Infection  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod Bite  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Arthropod Sting  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Soft Tissue Injury  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Skin Laceration  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Investigations         
Blood Glucose Increased  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Blood Cholesterol Increased  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Alanine Aminotransferase Increased  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Aspartate Aminotransferase Increased  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Blood Sodium Decreased  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/72 (0.00%)  0
Blood Triglycerides Increased  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Metabolism and nutrition disorders         
Anorexia  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Hypercholesterolaemia  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back Pain  1  3/37 (8.11%)  3 4/36 (11.11%)  4 0/36 (0.00%)  0 3/72 (4.17%)  3
Musculoskeletal Pain  1  2/37 (5.41%)  2 2/36 (5.56%)  2 1/36 (2.78%)  1 3/72 (4.17%)  3
Pain in Extremity  1  0/37 (0.00%)  0 2/36 (5.56%)  2 1/36 (2.78%)  1 3/72 (4.17%)  3
Neck Pain  1  1/37 (2.70%)  1 1/36 (2.78%)  1 1/36 (2.78%)  1 0/72 (0.00%)  0
Musculoskeletal Chest Pain  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Musculoskeletal Stiffness  1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 1/72 (1.39%)  1
Arthralgia  1  1/37 (2.70%)  1 2/36 (5.56%)  2 1/36 (2.78%)  1 5/72 (6.94%)  7
Muscle Spasms  1  1/37 (2.70%)  2 2/36 (5.56%)  2 1/36 (2.78%)  1 2/72 (2.78%)  2
Exostosis  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Bone Pain  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  2
Pain in Jaw  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Myalgia  1  0/37 (0.00%)  0 0/36 (0.00%)  0 2/36 (5.56%)  2 3/72 (4.17%)  3
Groin Pain  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Nervous system disorders         
Headache  1  7/37 (18.92%)  9 8/36 (22.22%)  11 10/36 (27.78%)  10 16/72 (22.22%)  26
Sinus Headache  1  1/37 (2.70%)  1 1/36 (2.78%)  2 1/36 (2.78%)  1 0/72 (0.00%)  0
Somnolence  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  10
Dizziness  1  2/37 (5.41%)  2 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  2
Dysgeusia  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Psychiatric disorders         
Anxiety  1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/72 (0.00%)  0
Abnormal Dreams  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders         
Nasal Congestion  1  0/37 (0.00%)  0 1/36 (2.78%)  1 1/36 (2.78%)  1 2/72 (2.78%)  2
Rhinitis Allergic  1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/72 (0.00%)  0
Sinus Congestion  1  0/37 (0.00%)  0 1/36 (2.78%)  1 1/36 (2.78%)  1 0/72 (0.00%)  0
Cough  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Pharyngolaryngeal Pain  1  1/37 (2.70%)  1 0/36 (0.00%)  0 1/36 (2.78%)  1 1/72 (1.39%)  1
Postnasal Drip  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Rhinorrhoea  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Sneezing  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/72 (1.39%)  1
Skin and subcutaneous tissue disorders         
Rash  1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/72 (0.00%)  0
Vascular disorders         
Hypertension  1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 2/72 (2.78%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577720     History of Changes
Other Study ID Numbers: 2005107
First Submitted: December 19, 2007
First Posted: December 20, 2007
Results First Submitted: August 12, 2011
Results First Posted: January 13, 2012
Last Update Posted: January 13, 2012