Trial Outcomes & Findings for Trial of Linaclotide in Patients With Chronic Constipation (NCT NCT00730015)
NCT ID: NCT00730015
Last Updated: 2013-01-30
Results Overview
A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
643 participants
Primary outcome timeframe
Change from Baseline to Week 12
Results posted on
2013-01-30
Participant Flow
Patient Recruitment occurred from August 2008 to August 2009 at 109 U.S. study centers.
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).
Participant milestones
| Measure |
Linaclotide, 145μg
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
Overall Study
STARTED
|
217
|
217
|
209
|
|
Overall Study
COMPLETED
|
186
|
177
|
177
|
|
Overall Study
NOT COMPLETED
|
31
|
40
|
32
|
Reasons for withdrawal
| Measure |
Linaclotide, 145μg
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
10
|
8
|
|
Overall Study
Protocol Violation
|
2
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
8
|
|
Overall Study
Lost to Follow-up
|
4
|
10
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
8
|
|
Overall Study
Other Reason
|
1
|
0
|
1
|
Baseline Characteristics
Trial of Linaclotide in Patients With Chronic Constipation
Baseline characteristics by cohort
| Measure |
Linaclotide, 145μg
n=217 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=217 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
47.1 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Age, Customized
18 years to 64 years
|
190 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
561 Participants
n=4 Participants
|
|
Age, Customized
65 years and older
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
562 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
217 participants
n=5 Participants
|
217 participants
n=7 Participants
|
209 participants
n=5 Participants
|
643 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.
A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. 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 |
Linaclotide, 145μg
n=217 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=216 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
|
46 participants
|
42 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug. 642 patients 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 |
Linaclotide, 145μg
n=217 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=216 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency
|
1.94 CSBMs per Week
Standard Error 0.17
|
2.04 CSBMs per Week
Standard Error 0.17
|
0.45 CSBMs per Week
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
The number of SBMs per week.
Outcome measures
| Measure |
Linaclotide, 145μg
n=217 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=216 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-Week Spontaneous Bowl Movement (SBM) Frequency
|
3.03 SBMs per Week
Standard Error 0.21
|
2.98 SBMs per Week
Standard Error 0.21
|
1.08 SBMs per Week
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.
The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale: 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 |
Linaclotide, 145μg
n=183 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=181 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=177 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-week Change in Stool Consistency
|
1.85 units on a scale
Standard Error 0.08
|
1.84 units on a scale
Standard Error 0.08
|
0.58 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.
Severity of 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 |
Linaclotide, 145μg
n=183 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=181 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=177 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-week Change in Severity of Straining
|
-1.12 units on a scale
Standard Error 0.05
|
-1.15 units on a scale
Standard Error 0.05
|
-0.51 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Outcome measures
| Measure |
Linaclotide, 145μg
n=217 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=216 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-week Change in Abdominal Discomfort
|
-0.49 units on a scale
Standard Error 0.04
|
-0.44 units on a scale
Standard Error 0.04
|
-0.30 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Outcome measures
| Measure |
Linaclotide, 145μg
n=217 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=216 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-week Change in Bloating
|
-0.46 units on a scale
Standard Error 0.04
|
-0.37 units on a scale
Standard Error 0.04
|
-0.22 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: 643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.
Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".
Outcome measures
| Measure |
Linaclotide, 145μg
n=213 Participants
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide, 290μg
n=210 Participants
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 Participants
Dose matched placebo, oral administration, once per day
|
|---|---|---|---|
|
12-week Change in Constipation Severity
|
-0.90 units on a scale
Standard Error 0.05
|
-0.81 units on a scale
Standard Error 0.05
|
-0.27 units on a scale
Standard Error 0.05
|
Adverse Events
Linaclotide 145μg
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Linaclotide 290μg
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Linaclotide 145μg to Placebo RW Period
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Linaclotide 145μg to Linaclotide 145μg RW Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Linaclotide 290μg to Placebo RW Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Linaclotide 290μg to Linaclotide 290μg RW Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Linaclotide 145μg
n=217 participants at risk
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide 290μg
n=217 participants at risk
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 participants at risk
Dose matched placebo, oral administration, once per day
|
Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period
n=177 participants at risk
Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
|
Linaclotide 145μg to Placebo RW Period
n=95 participants at risk
Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
|
Linaclotide 145μg to Linaclotide 145μg RW Period
n=90 participants at risk
Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
|
Linaclotide 290μg to Placebo RW Period
n=86 participants at risk
Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
|
Linaclotide 290μg to Linaclotide 290μg RW Period
n=90 participants at risk
Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.48%
1/209 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.96%
2/209 • Number of events 2 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
1.1%
1/95 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Infections and infestations
Pneumonia
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.48%
1/209 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumor benign
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.48%
1/209 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.48%
1/209 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Cardiac disorders
Chest pain
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Reproductive system and breast disorders
Ectopic pregnancy
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Gastrointestinal disorders
Diverticulum intestinal hemorrhagic
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
1.1%
1/95 • Number of events 1 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
Other adverse events
| Measure |
Linaclotide 145μg
n=217 participants at risk
Linaclotide, 145μg dose, oral administration, once per day
|
Linaclotide 290μg
n=217 participants at risk
Linaclotide, 290μg dose, oral administration, once per day
|
Placebo
n=209 participants at risk
Dose matched placebo, oral administration, once per day
|
Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period
n=177 participants at risk
Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
|
Linaclotide 145μg to Placebo RW Period
n=95 participants at risk
Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
|
Linaclotide 145μg to Linaclotide 145μg RW Period
n=90 participants at risk
Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
|
Linaclotide 290μg to Placebo RW Period
n=86 participants at risk
Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
|
Linaclotide 290μg to Linaclotide 290μg RW Period
n=90 participants at risk
Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.4%
27/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
13.8%
30/217 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
6.7%
14/209 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
11.3%
20/177 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
1.1%
1/95 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
2.2%
2/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
0.00%
0/86 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
1.1%
1/90 • Adverse Event data were collected from October 2008 through October 2009. The Treatment Period lasted 12 weeks and the Randomized Withdrawal (RW) Period started after the Treamtent Period and lasted 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that publication cannot be made for 24 months from the date of final data lock of the study, the sponsor can review the publication prior to public release, sponsor requires a minimum 60 day review period for each publication, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request an additional delay period of 60 days in order to protect potentially patentable information.
- Publication restrictions are in place
Restriction type: OTHER