Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

• Sponsor: Sucampo Pharma Americas, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02766777
• Collaborator: Sucampo AG (Industry)
• Enrollment: 87
• Locations: 13
• Arm: 1
• Actual Duration (Months): 6.8
• Patients Per Site: 6.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.

Condition or Disease	Intervention/Treatment	Phase
Constipation - Functional	Drug: Lubiprostone	Phase 3

Detailed Description

To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
• Actual Study Start Date: Apr 12, 2016
• Actual Primary Completion Date: Nov 4, 2016
• Actual Study Completion Date: Nov 4, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lubiprostone Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.	Drug: Lubiprostone; 12 or 24 mcg soft capsules for oral administration.; Other Names: Amitiza

Outcome Measures

Primary Outcome Measures

1. Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [within 25 weeks]

   Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation

• At least 6 years of age but less than 18 years of age at the time of randomisation

• Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants

Exclusion Criteria:

• Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation

• Untreated faecal impaction at the time of screening

• Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest Arkansas Pediatric Clinic	Fayetteville	Arkansas	United States	72703
2	Methodist Medical Center	Peoria	Illinois	United States	61602
3	Willis-Knighton Physician Network	Shreveport	Louisiana	United States	71101
4	Pioneer Clinical Research	Bellevue	Nebraska	United States	68005
5	PriMed Clinical Research	Beavercreek	Ohio	United States	45431
6	Cyn3rgy Research	Gresham	Oregon	United States	97030
7	Coastal Clinical Research	Charleston	South Carolina	United States	29414
8	Coastal Pediatrics Associates - Mount Pleasant	Mount Pleasant	South Carolina	United States	29464
9	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
10	3rd Coast Research Associates	Corpus Christi	Texas	United States	78413
11	Bridgerland Clinical Research	Logan	Utah	United States	84341
12	Wee Care Pediatrics	Syracuse	Utah	United States	84075
13	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia	United States	22902

Sponsors and Collaborators

• Sucampo Pharma Americas, LLC
• Sucampo AG

Investigators

• Study Director: Clinical Team Leader, Mallinckrodt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sucampo Pharma Americas, LLC
• ClinicalTrials.gov Identifier: NCT02766777
• Other Study ID Numbers: SCMP-0211-303
• First Posted: May 10, 2016
• Last Update Posted: May 15, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Constipation; Lubiprostone

Study Results

Participant Flow

Arm/Group Title	Lubiprostone
Arm/Group Description	Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Period Title: Overall Study
STARTED	87
Treated (Safety [SAF] Population)	87
COMPLETED	53
NOT COMPLETED	34

Baseline Characteristics

Arm/Group Title	Lubiprostone
Arm/Group Description	Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Overall Participants	87
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.3 (3.03)
Sex: Female, Male (Count of Participants)
Female	49 56.3%
Male	38 43.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 11.5%
Not Hispanic or Latino	77 88.5%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	16 18.4%
White	68 78.2%
Other	3 3.4%
Region of Enrollment (Count of Participants)
United States	87 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Description	Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.
Time Frame	within 25 weeks

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Lubiprostone
Arm/Group Description	Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Measure Participants	87
Count of Participants [Participants]	47 54%

Adverse Events

Time Frame	From the first dose of study drug up to 25 weeks
Arm/Group Title	Lubiprostone
Arm/Group Description	Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
All Cause Mortality
	Lubiprostone
	Affected / at Risk (%)	# Events
Total	0/87 (0%)
Serious Adverse Events
	Lubiprostone
	Affected / at Risk (%)	# Events
Total	2/87 (2.3%)
Gastrointestinal disorders
Colitis ulcerative	1/87 (1.1%)
Constipation	1/87 (1.1%)
Other (Not Including Serious) Adverse Events
	Lubiprostone
	Affected / at Risk (%)	# Events
Total	24/87 (27.6%)
Gastrointestinal disorders
Diarrhoea	8/87 (9.2%)
Vomiting	6/87 (6.9%)
Nausea	5/87 (5.7%)
Investigations
Blood iron decreased	5/87 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.