Trial Outcomes & Findings for Long Term Safety Study of Plecanatide (NCT NCT02706483)
NCT ID: NCT02706483
Last Updated: 2020-08-18
Results Overview
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2272 participants
Primary outcome timeframe
up to 53 weeks
Results posted on
2020-08-18
Participant Flow
Eligible subjects with IBS-C from SP304203-04 (NCT02387359), SP304203-05 (NCT02493452), and SP304-20212 (NCT01722318), and subjects that did not previously participate in any plecanatide study, were enrolled.
Participant milestones
| Measure |
Plecanatide
Plecanatide 6.0 mg tablets
Plecanatide
|
|---|---|
|
Overall Study
STARTED
|
2272
|
|
Overall Study
COMPLETED
|
1842
|
|
Overall Study
NOT COMPLETED
|
430
|
Reasons for withdrawal
| Measure |
Plecanatide
Plecanatide 6.0 mg tablets
Plecanatide
|
|---|---|
|
Overall Study
Adverse Event
|
97
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
39
|
|
Overall Study
Lost to Follow-up
|
101
|
|
Overall Study
Non-compliance with study drug
|
15
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Pregnancy
|
6
|
|
Overall Study
Protocol Violation
|
18
|
|
Overall Study
Withdrawal by Subject
|
136
|
|
Overall Study
Non-compliance with visits
|
6
|
|
Overall Study
Site closure
|
4
|
|
Overall Study
Subject moved
|
1
|
Baseline Characteristics
Participants with height and weight information are included.
Baseline characteristics by cohort
| Measure |
Plecanatide
n=2272 Participants
Plecanatide 6.0 mg tablets
Plecanatide
|
|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 14.18 • n=2272 Participants
|
|
Sex: Female, Male
Female
|
1744 Participants
n=2272 Participants
|
|
Sex: Female, Male
Male
|
528 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
Asian
|
55 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
504 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
White
|
1692 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=2272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2272 Participants
|
|
Body Mass Index
|
28.4 kilograms per meters squared
STANDARD_DEVIATION 4.87 • n=2269 Participants • Participants with height and weight information are included.
|
PRIMARY outcome
Timeframe: up to 53 weeksNumber of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
Outcome measures
| Measure |
Plecanatide
n=2272 Participants
Plecanatide 6.0 mg tablets
Plecanatide
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events.
|
205 Participants
|
Adverse Events
Plecanatide
Serious events: 45 serious events
Other events: 341 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Plecanatide
n=2272 participants at risk
Plecanatide 6.0 mg tablets
Plecanatide
|
|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
0.26%
6/2272 • Number of events 6 • Up to 53 weeks.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.22%
5/2272 • Number of events 5 • Up to 53 weeks.
|
|
Investigations
Liver Function Test Abnormal
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Investigations
Transaminases Increased
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.13%
3/2272 • Number of events 3 • Up to 53 weeks.
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Cellulitis
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Clostridial Infection
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Meningitis Viral
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Pneumonia
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Urinary Tract Infection
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Infections and infestations
Viral Infection
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.09%
2/2272 • Number of events 2 • Up to 53 weeks.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.09%
2/2272 • Number of events 3 • Up to 53 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.09%
2/2272 • Number of events 2 • Up to 53 weeks.
|
|
General disorders
Chest Pain
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Cardiac disorders
Angina Unstable
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.04%
1/2272 • Number of events 1 • Up to 53 weeks.
|
Other adverse events
| Measure |
Plecanatide
n=2272 participants at risk
Plecanatide 6.0 mg tablets
Plecanatide
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
153/2272 • Up to 53 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
29/2272 • Up to 53 weeks.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.9%
43/2272 • Up to 53 weeks.
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
34/2272 • Up to 53 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
34/2272 • Up to 53 weeks.
|
|
Infections and infestations
Sinusitis
|
1.0%
23/2272 • Up to 53 weeks.
|
|
Nervous system disorders
Headache
|
1.1%
25/2272 • Up to 53 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER