Safety and Efficacy of Lubiprostone in Pediatric Patients... | NCT00452335

NCT00452335

Status Module

Sponsor/Collaborators Module

Name	Class
Sucampo Pharmaceuticals, Inc.	INDUSTRY

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
Lubiprostone 12 mcg QD	Experimental	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight	Drug: Lubiprostone
Lubiprostone 12 mcg BID	Experimental	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight	Drug: Lubiprostone
Lubiprostone 24 mcg BID	Experimental	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight	Drug: Lubiprostone

Name	Type	Description	Arm Group Labels	Other Names
Lubiprostone	Drug	12 mcg capsule once daily (QD)	Lubiprostone 12 mcg QD

Outcomes Module

Measure	Description	Time Frame
Frequency of Spontaneous Bowel Movements	Gathered as part of the daily electronic diary questions.	Week 1

Secondary Outcomes

Measure	Description	Time Frame
Frequency of Spontaneous Bowel Movements	Gathered as part of the daily electronic diary questions.	Weeks 2, 3, and 4
Frequency of Fecal Incontinence	As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Paul Hyman, MD	University of Kansas Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children's Hospital		Phoenix	Arizona	85016	United States
Arkansas Pediatric Clinic

References Module

No data available

No data is available for this block.

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	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
FG001	12 mcg BID

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

Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
BG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
BG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00027 BG00165 BG00232 BG003124

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00027 BG00165 BG00232 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0005.5± 1.67 BG00110.3± 2.78 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012 BG00124 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00027 BG00165 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Frequency of Spontaneous Bowel Movements

Gathered as part of the daily electronic diary questions.

ITT population

Posted

Mean

Standard Deviation

spontaneous bowel movements per week

Week 1

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants	OG00027 OG00165 OG00231

Title

Denominators

Categories

Title	Measurements
	OG0002.47± 2.68 OG0013.02± 2.17 OG0023.84± 2.51

Secondary

Frequency of Spontaneous Bowel Movements

Gathered as part of the daily electronic diary questions.

ITT Population

Posted

Mean

Standard Deviation

spontaneous bowel movements per week

Weeks 2, 3, and 4

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Frequency of Fecal Incontinence

As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.

ITT Population

Posted

Mean

Standard Deviation

episodes of fecal incontinence per day

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Straining Associated With SBMs

Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 Mch BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Stool Consistency of SBMs

Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 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, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Secondary

Abdominal Bloating

Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Abdominal Discomfort

Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG001	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Pain Associated With SBMs

Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Constipation Severity

Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Secondary

Treatment Effectiveness

Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Weekly, up to 4 weeks

ID	Title	Description
OG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
OG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
OG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	12 mcg QD	Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight	0	27	5	27
EG001	12 mcg BID	Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight	1	65	23	65
EG002	24 mcg BID	Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight	0	32	14	32

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1			EG0000 affected27 at risk EG0011 affected65 at risk EG0020 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1	EG0002 affected27 at risk EG0014 affected65 at risk EG0023 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	EG0003 affected27 at risk EG0014 affected65 at risk EG0023 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	EG0001 affected27 at risk EG00112 affected65 at risk EG00210 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	EG0004 affected27 at risk EG0016 affected65 at risk EG0025 affected32 at risk
Headache	Nervous system disorders	MedDRA 10.1	EG0000 affected27 at risk EG0014 affected65 at risk EG0023 affected32 at risk

ID	Term
D003248	Constipation

ID	Term
D000068238	Lubiprostone

OG00027
OG00165
OG00231

OG00027
OG00165
OG00231

OG00027
OG00165
OG00231

OG00027
OG00165
OG00231

OG00027
OG00165
OG00231

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000527	Alprostadil
D005229	Fatty Acids, Monounsaturated
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids