Trial Outcomes & Findings for The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) (NCT NCT01722318)
NCT ID: NCT01722318
Last Updated: 2019-05-28
Results Overview
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
428 participants
Primary outcome timeframe
12 weeks Treatment Period
Results posted on
2019-05-28
Participant Flow
The Enrollment number in the Protocol Section was changed from 350 to 428 participants to reflect the actual enrollment number.
Participant milestones
| Measure |
Plecanatide 0.3mg
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 1.0mg
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 3.0mg
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 9.0mg
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Placebo
Placebo, one tablet by mouth daily for 12 weeks
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
86
|
85
|
86
|
|
Overall Study
COMPLETED
|
72
|
65
|
66
|
65
|
68
|
|
Overall Study
NOT COMPLETED
|
14
|
20
|
20
|
20
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Baseline characteristics by cohort
| Measure |
Plecanatide 0.3mg
n=84 Participants
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 1.0mg
n=83 Participants
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 3.0mg
n=86 Participants
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 9.0mg
n=85 Participants
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Placebo
n=85 Participants
Placebo, one tablet by mouth daily for 12 weeks
Placebo
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 12.58 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 12.00 • n=4 Participants
|
45.4 years
STANDARD_DEVIATION 12.02 • n=21 Participants
|
45.9 years
STANDARD_DEVIATION 12.30 • n=8 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
344 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
79 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeks Treatment PeriodPopulation: The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.
Outcome measures
| Measure |
Plecanatide 0.3mg
n=84 Participants
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 1.0mg
n=83 Participants
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
|
Plecanatide 3.0mg
n=86 Participants
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 9.0mg
n=85 Participants
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
|
Placebo
n=85 Participants
Placebo, one tablet by mouth daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
|
1.28 CSBMs per week
Standard Error 0.260
|
2.12 CSBMs per week
Standard Error 0.265
|
2.74 CSBMs per week
Standard Error 0.260
|
2.44 CSBMs per week
Standard Error 0.262
|
1.27 CSBMs per week
Standard Error 0.260
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The mITT population included all randomized patients who received at least 1 dose of study drug and who had at least 1 post-baseline Bowel Movement (BM) assessment was the primary analysis population for efficacy endpoints.
Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.
Outcome measures
| Measure |
Plecanatide 0.3mg
n=84 Participants
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 1.0mg
n=83 Participants
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
|
Plecanatide 3.0mg
n=86 Participants
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 9.0mg
n=85 Participants
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
|
Placebo
n=85 Participants
Placebo, one tablet by mouth daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
|
-1.5 scores on a scale
Standard Error 0.20
|
-1.5 scores on a scale
Standard Error 0.20
|
-2.0 scores on a scale
Standard Error 0.20
|
-1.8 scores on a scale
Standard Error 0.20
|
-1.4 scores on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.
The stool consistency of each bowel movement (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 its 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 |
Plecanatide 0.3mg
n=84 Participants
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 1.0mg
n=83 Participants
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
|
Plecanatide 3.0mg
n=86 Participants
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 9.0mg
n=85 Participants
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
|
Placebo
n=85 Participants
Placebo, one tablet by mouth daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
|
1.63 scores on a scale
Standard Error 0.143
|
1.81 scores on a scale
Standard Error 0.144
|
2.49 scores on a scale
Standard Error 0.143
|
2.24 scores on a scale
Standard Error 0.145
|
1.01 scores on a scale
Standard Error 0.143
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.
The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe
Outcome measures
| Measure |
Plecanatide 0.3mg
n=84 Participants
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 1.0mg
n=83 Participants
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
|
Plecanatide 3.0mg
n=86 Participants
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
|
Plecanatide 9.0mg
n=85 Participants
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
|
Placebo
n=85 Participants
Placebo, one tablet by mouth daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)
|
-1.7 score on a scale
Standard Error 0.23
|
-1.5 score on a scale
Standard Error 0.23
|
-2.2 score on a scale
Standard Error 0.23
|
-2.1 score on a scale
Standard Error 0.24
|
-1.3 score on a scale
Standard Error 0.23
|
Adverse Events
Plecanatide 0.3mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Plecanatide 1.0mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Plecanatide 3.0mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Plecanatide 9.0mg
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plecanatide 0.3mg
n=85 participants at risk
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 1.0mg
n=85 participants at risk
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 3.0mg
n=86 participants at risk
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 9.0mg
n=85 participants at risk
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Placebo
n=86 participants at risk
Placebo, one tablet by mouth daily for 12 weeks
Placebo
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/86 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/85 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
Other adverse events
| Measure |
Plecanatide 0.3mg
n=85 participants at risk
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 1.0mg
n=85 participants at risk
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 3.0mg
n=86 participants at risk
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Plecanatide 9.0mg
n=85 participants at risk
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Plecanatide
|
Placebo
n=86 participants at risk
Placebo, one tablet by mouth daily for 12 weeks
Placebo
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
3/85 • Number of events 3 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
9.4%
8/85 • Number of events 8 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
9.3%
8/86 • Number of events 9 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
11.8%
10/85 • Number of events 12 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
4/85 • Number of events 4 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
2.3%
2/86 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
4.7%
4/85 • Number of events 4 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
5.8%
5/86 • Number of events 6 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
5.9%
5/85 • Number of events 5 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
3.5%
3/86 • Number of events 5 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/86 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Nervous system disorders
Headache
|
2.4%
2/85 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
5.9%
5/85 • Number of events 5 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
3.5%
3/86 • Number of events 3 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
9.4%
8/85 • Number of events 8 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
4.7%
4/86 • Number of events 4 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
4.7%
4/85 • Number of events 4 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
2.4%
2/85 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.5%
3/85 • Number of events 3 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
3.5%
3/85 • Number of events 3 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/86 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
2/85 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
2.4%
2/85 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/86 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
3.5%
3/85 • Number of events 3 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/86 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
|
General disorders
Fatigue
|
2.4%
2/85 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
1.2%
1/85 • Number of events 1 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
2.3%
2/86 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
2.4%
2/85 • Number of events 2 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
|
0.00%
0/86 • 12 weeks
A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
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Additional Information
Dr. Patrick H. Griffin
Synergy Pharmaceuticals Inc.
Phone: 212-297-0020
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place