Open-label Extension (OLE) Study of Plecanatide for Chron... | NCT01919697

NCT01919697

Status Module

Sponsor/Collaborators Module

Name	Class
Syneos Health	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plecanatide 3.0 mg	Experimental	Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks	Drug: Plecanatide
Plecanatide 6.0 mg	Experimental	Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks	Drug: Plecanatide

Name	Type	Description	Arm Group Labels	Other Names
Plecanatide	Drug		Plecanatide 3.0 mg Plecanatide 6.0 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)	All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.	From first dose up to 72 weeks
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide	Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Body Temperature (°C)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

Secondary Outcomes

Measure	Description	Time Frame
Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364	Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.	Form first dose up to 72 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Richard A Krause, MD	ClinSearch, LLC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Synergy Research Site		Birmingham	Alabama	35242	United States
Synergy Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29343131	Derived	Barish CF, Griffin P. Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study. Curr Med Res Opin. 2018 Apr;34(4):751-755. doi: 10.1080/03007995.2018.1430024. Epub 2018 Feb 2.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
FG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for up to 72 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

A total of 2321 patients were based on the Safety Population (2370) excluding all duplicate patients except identified as "Index" patients. "Index" was duplicate patients appeared the first time in the enrollment.

Arm/Group Information

ID	Title	Description
BG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
BG001	Plecanatide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for up to 72 weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000123 OG001620

Primary

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug

The Safety Population consisted of all enrolled patients who had at least one dose of the study drug.

Posted

Count of Participants

Participants

From first dose up to 72 weeks

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Primary

Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

mmHg

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Primary

Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

beats per minute

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Primary

Summary of Vital Signs at >Day 364 - Body Temperature (°C)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

°C

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Primary

Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

breaths per minute

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Primary

Summary of ECG Results Shift From Baseline at > Day 364

Baseline was defined as the last non-missing value collected prior to first dose of study drug)

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Number

participants

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Primary

Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Number

participants

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Secondary

Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

score on a scale

Form first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Secondary

Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

All enrolled patients who had at least one dose of the study drug and had at least one post-baseline Patient Global Assessment (PGA) were included in this population. A total of 2378 patients including the re-enrolled patients who previously participated and completed this open-label study was used for assessments.

Posted

Mean

Standard Deviation

score on a scale

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants

Secondary

Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

score on a scale

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Secondary

Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely

This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.

Posted

Mean

Standard Deviation

score on a scale

From first dose up to 72 weeks

Readings

ID	Title	Description
OG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks
OG001	Plecantide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Plecanatide 3 mg	Plecanatide 3 mg, one tablet by mouth daily for 72 weeks	0	224	8	224	32	224
EG001	Plecanatide 6 mg	Plecanatide 6 mg, one tablet by mouth daily for 72 weeks	1	2,146	32	2,146	188	2,146

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0017 events7 affected2,146 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected2,146 at risk
Diverticulitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected2,146 at risk
Appendicitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Gastroenteritis	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Liver abscess	Infections and infestations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Alanine aminotransferase increased	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected2,146 at risk
Aspartate aminotransferase abnormal	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Electrocardiogram change	Investigations	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected2,146 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Vomiting	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected2,146 at risk
Myocardial infarction	Cardiac disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected2,146 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected2,146 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected2,146 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected2,146 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Non-cardiac chest pain	General disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected2,146 at risk
Hypotension	Vascular disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected2,146 at risk
Thrombosis	Vascular disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (14.1)	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected2,146 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected2,146 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Systematic Assessment		EG00024 events19 affected224 at risk EG001159 events150 affected2,146 at risk
Urinary tract infection	Infections and infestations	MedDRA (14.1)	Systematic Assessment		EG00015 events13 affected224 at risk EG00140 events38 affected2,146 at risk

ID	Term
D000092122	Bronchiolitis Obliterans Syndrome
D003248	Constipation

Ancestor Terms

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D006086	Graft vs Host Disease
D007154	Immune System Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C584575	plecanatide

Units	Counts
Participants	OG000224 OG0012146
Readings	OG000224 OG0012154