Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

NCT00452335 | Completed Phase 4 Results

• 1 other identifier: 0211SC-0641
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 19

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Frequency of Spontaneous Bowel Movements

  Gathered as part of the daily electronic diary questions.

  Week 1

Secondary Outcomes (9)

• Frequency of Spontaneous Bowel Movements

  Weeks 2, 3, and 4

• Frequency of Fecal Incontinence

  Weekly, up to 4 weeks

• Straining Associated With SBMs

  Weekly, up to 4 weeks

• Stool Consistency of SBMs

  Weekly, up to 4 weeks

• Abdominal Bloating

  Weekly, up to 4 weeks

Study Arms (3)

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

Interventions

Lubiprostone DRUG

12 mcg capsule once daily (QD)

Also known as: Amitiza®

Lubiprostone 12 mcg QD

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Less than 18 years of age
• Weight of at least 12 kg and capable of swallowing a capsule
• Able to refrain from use of medications known to treat or associated with constipation symptoms
• Stable fiber therapy or ADHD therapy if using such medications
• Patient/Caregiver able to complete daily diary
• Patient able to use recommended rectal and/or oral rescue medications if needed

You may not qualify if:

• Constipation is associated with some medical, anatomic, physical, organic, or other condition
• Hirschsprung's Disease or Nonretentive Fecal Incontinence
• Untreated fecal impactions or impactions requiring digital manipulation
• Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
• Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
• Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
• If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
• Sexually active males and females must utilize acceptable birth control methods
• Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211

Sponsors & Collaborators

• Sucampo Pharma Americas, LLC: lead
• Sucampo Pharmaceuticals, Inc.: collaborator

Study Sites (19)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Arkansas Pediatric Clinic

Little Rock, Arkansas, 72005, United States

Location

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

Center for Children's Digestive Health

Park Ridge, Illinois, 60068, United States

Location

University of Illinois at Peoria

Peoria, Illinois, 61613, United States

Location

University of Illinois at Chicago

Springfield, Illinois, 62708-0787, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

The Center for Human Nutrition, Inc.

Omaha, Nebraska, 68105, United States

Location

AHS Hospital Corporation

Morristown, New Jersey, 07962, United States

Location

Children's Research Institute

Columbus, Ohio, 43205, United States

Location

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, 45014, United States

Location

Regional Gastroenterology Associates of Lancaster, Ltd.

Lancaster, Pennsylvania, 17604, United States

Location

Southeastern Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: VP, Clinical Development
• Organization: Sucampo Pharma Americas, Inc.

info@sucampo.com

301-961-3400

Study Officials

• Paul Hyman, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 17, 2019
• Results First Posted: August 22, 2016

Record last verified: 2016-07

Locations

US (19)