Trial Outcomes & Findings for Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (NCT NCT00948818)
NCT ID: NCT00948818
Last Updated: 2013-01-30
Results Overview
A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.
COMPLETED
PHASE3
803 participants
Change from Baseline to Week 12
2013-01-30
Participant Flow
Patient recruitment occurred over an eight month period from July 2009 to March 2009 at 118 study sites (111 in the United States, 7 in Canada).
Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS). All randomized patients needed an abdominal pain score ≥ 3. One randomized patient in the Placebo arm did not receive study drug.
Participant milestones
| Measure |
Placebo
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Overall Study
STARTED
|
397
|
406
|
|
Overall Study
COMPLETED
|
335
|
312
|
|
Overall Study
NOT COMPLETED
|
62
|
94
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
32
|
|
Overall Study
Protocol Violation
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
25
|
25
|
|
Overall Study
Lost to Follow-up
|
10
|
17
|
|
Overall Study
Lack of Efficacy
|
4
|
5
|
|
Overall Study
Other Reason
|
4
|
5
|
Baseline Characteristics
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Baseline characteristics by cohort
| Measure |
Placebo
n=396 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=406 Participants
Linaclotide 290µg, oral administration, once per day.
|
Total
n=802 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Canada
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Age Continuous
|
43.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Age, Customized
18 years to 64 years
|
370 participants
n=5 Participants
|
387 participants
n=7 Participants
|
757 participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
358 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
726 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
367 participants
n=5 Participants
|
374 participants
n=7 Participants
|
741 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.
A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
Responder
|
20 Participants
|
49 Participants
|
|
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
Nonresponder
|
375 Participants
|
356 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
Responder
|
25 Participant
|
79 Participant
|
|
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
Non-responder
|
370 Participant
|
326 Participant
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Abdominal Pain Responder, 9 Out of 12 Weeks
Responder
|
107 Participants
|
139 Participants
|
|
Abdominal Pain Responder, 9 Out of 12 Weeks
Non-responder
|
288 Participants
|
266 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.
Non-responder
|
312 Participants
|
269 Participants
|
|
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.
Responder
|
83 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
The number of CSBMs per week.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
|
0.705 CSBMs per Week
Standard Error 0.128
|
2.272 CSBMs per Week
Standard Error 0.127
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
The number of Spontaneous Bowl Movements experienced per week.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Spontaneous Bowl Movement (SBM) Frequency Rate
|
1.130 SBMs per week
Standard Error .0177
|
3.898 SBMs per week
Standard Error 0.176
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.
The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7. 1. = separate hard lumps like nuts \[difficult to pass\] 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges \[passed easily\] 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces \[entirely liquid\]).
Outcome measures
| Measure |
Placebo
n=338 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=355 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Stool Consistency
|
0.662 units on a scale
Standard Error 0.061
|
2.071 units on a scale
Standard Error 0.060
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.
Straining is measured on a 5-point scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount.
Outcome measures
| Measure |
Placebo
n=338 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=355 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Severity of Straining
|
-0.651 units on a scale
Standard Error 0.042
|
-1.306 units on a scale
Standard Error 0.042
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Change in Abdominal Pain Score
|
-1.129 units on a scale
Standard Error 0.094
|
-1.869 units on a scale
Standard Error 0.093
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Change in Abdominal Discomfort
|
-1.211 units on a scale
Standard Error 0.097
|
-1.953 units on a scale
Standard Error 0.096
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Change in Bloating
|
-1.100 units on a scale
Standard Error 0.100
|
-1.944 units on a scale
Standard Error 0.099
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
Responder
|
117 Participants
|
197 Participants
|
|
Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
Non-responder
|
278 Participants
|
208 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
Abdominal Pain Responder for 6 Out of 12 Weeks
Non-Responder
|
247 Participants
|
202 Participants
|
|
Abdominal Pain Responder for 6 Out of 12 Weeks
Responder
|
148 Participants
|
203 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Outcome measures
| Measure |
Placebo
n=395 Participants
Dose-matched placebo, oral administration, once per day.
|
Linaclotide
n=405 Participants
Linaclotide 290µg, oral administration, once per day.
|
|---|---|---|
|
12-Week Percent of Abdominal Pain-free (APF) Days
|
5.31 Percent
Standard Deviation 15.74
|
9.81 Percent
Standard Deviation 21.75
|
Adverse Events
Placebo - Treatment Period
Linaclotide - Treatment Period
Placebo to Linaclotide - Randomized Withdrawal Period
Linaclotide to Placebo - Randomized Withdrawal Period
Linaclotide to Linaclotide - Randomized Withdrawal Period
Serious adverse events
| Measure |
Placebo - Treatment Period
n=396 participants at risk
Dose-matched placebo, oral administration, once per day.
|
Linaclotide - Treatment Period
n=406 participants at risk
Linaclotide 290µg, oral administration, once per day.
|
Placebo to Linaclotide - Randomized Withdrawal Period
n=333 participants at risk
Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.
This group had previously received dose-matched placebo during the 12-week randomized treatment period.
|
Linaclotide to Placebo - Randomized Withdrawal Period
n=154 participants at risk
Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.
This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period.
|
Linaclotide to Linaclotide - Randomized Withdrawal Period
n=158 participants at risk
Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.25%
1/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.25%
1/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.25%
1/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Gastrointestinal disorders
Duodenitis
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Renal and urinary disorders
Renal cyst
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.25%
1/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
Other adverse events
| Measure |
Placebo - Treatment Period
n=396 participants at risk
Dose-matched placebo, oral administration, once per day.
|
Linaclotide - Treatment Period
n=406 participants at risk
Linaclotide 290µg, oral administration, once per day.
|
Placebo to Linaclotide - Randomized Withdrawal Period
n=333 participants at risk
Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.
This group had previously received dose-matched placebo during the 12-week randomized treatment period.
|
Linaclotide to Placebo - Randomized Withdrawal Period
n=154 participants at risk
Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.
This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period.
|
Linaclotide to Linaclotide - Randomized Withdrawal Period
n=158 participants at risk
Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
|
|---|---|---|---|---|---|
|
General disorders
Diarrhea
|
3.5%
14/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
19.5%
79/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
11.7%
39/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.65%
1/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
1.9%
3/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
10/396 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
5.4%
22/406 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
2.4%
8/333 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
0.00%
0/154 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
1.3%
2/158 • Adverse event data for the treatment period was collected from July of 2009 to July of 2010
803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.
|
Additional Information
Paul F.C. Eng Ph.D Director, Clinical Development
Forest Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this trial will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the trial. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER