Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

• Sponsor: University of South Alabama (Other)
• Overall Status: Completed
• CT.gov ID: NCT00746395
• Collaborator: Takeda (Industry), Sucampo Pharmaceuticals, Inc. (Industry)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Drug: Lubiprostone; Drug: Placebo	Phase 4

Detailed Description

Introduction of small bowel capsule endoscopy made available an unique technique for diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides small bowel yield. Capsule endoscopy has special application for evaluation of inflammation bowel disease and other small bowel conditions. Several adjuncts are used to enhance the examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod, simethicone, erythromycin, phosphates and polyethylene glycol (PEG) colon cleansing agents have been tried and some show improved visualization or increased propulsion where more capsules reach to colonic cecum while still recording within the limits of its 8 hour battery. Recently, our group had an observational report of our experience showing that either full bowel cleansing preparation or prokinetics such as metoclopramide or tegaserod enhanced visualization and functioning capsule transit to the colon. Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation.

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose was chosen because other medications used in similar single dose in our pilot studies appear effective.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lubiprostone 24mcg single dose lubiprostone 24mcg single dose po prior to capsule endoscopy	Drug: Lubiprostone; 24 mcg oral administration; Other Names: Amitiza
Placebo Comparator: Sugar pill Placebo (sugar pill) - matched single dose po prior to capsule endoscopy	Drug: Placebo; Oral administration; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Complete Small Bowel Transit [8 hours]

   Percent of subjects with capsule passage through small bowel

Secondary Outcome Measures

1. Small Bowel Transit [Duration of the test - 8 hours]

   Small bowel transit time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USA Pavilion at Infirmary West	Mobile	Alabama	United States	36693

Sponsors and Collaborators

• University of South Alabama
• Takeda
• Sucampo Pharmaceuticals, Inc.

Investigators

• Principal Investigator: JAck A DiPalma, MD, University of South Alabama

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Alabama
• ClinicalTrials.gov Identifier: NCT00746395
• Other Study ID Numbers: 07-096
• First Posted: Sep 4, 2008
• Last Update Posted: Oct 8, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by University of South Alabama: capsule; endoscopy; prokinetic; lubiprostone; Normal; volunteers
• Additional relevant MeSH terms: Inflammatory Bowel Diseases; Lubiprostone

Study Results

Participant Flow

Recruitment Details	Participants recruited from a specialty clinic in Mobile, AL, USA between April 2008 and September 2008.
Pre-assignment Detail	45 participants recruited and screened, 1 excluded, 4 withdrew from study.

Arm/Group Title	Lubiprostone 24mcg Single Dose	Sugar Pill
Arm/Group Description	lubiprostone 24mcg single dose po prior to capsule endoscopy	Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lubiprostone 24mcg Single Dose	Sugar Pill	Total
Arm/Group Description	lubiprostone 24mcg single dose po prior to capsule endoscopy	Placebo (sugar pill) - matched single dose po prior to capsule endoscopy	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	20 100%	40 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.75 (13.15045)	35.4 (10.86472)	37.07 (2.36881)
Sex: Female, Male (Count of Participants)
Female	15 75%	12 60%	27 67.5%
Male	5 25%	8 40%	13 32.5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Complete Small Bowel Transit
Description	Percent of subjects with capsule passage through small bowel
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

Placebo 95%, lubiprostone 75%

Arm/Group Title	Lubiprostone 24mcg Single Dose	Sugar Pill
Arm/Group Description	lubiprostone 24mcg single dose po prior to capsule endoscopy	Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
Measure Participants	20	20
Number [percentage of subjects with passage]	75	95

2. Secondary Outcome

Title	Small Bowel Transit
Description	Small bowel transit time
Time Frame	Duration of the test - 8 hours

Outcome Measure Data

Analysis Population Description

Patients without transit to cecum were excluded

Arm/Group Title	Lubiprostone 24mcg Single Dose	Sugar Pill
Arm/Group Description	lubiprostone 24mcg single dose po prior to capsule endoscopy	Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
Measure Participants	15	19
Mean (Standard Error) [Minutes]	188.1 (68.0)	218.9 (89.0)

Adverse Events

Time Frame	From the administration of the drug through the end of the procedure.
Adverse Event Reporting Description	No serious adverse events during study duration
Arm/Group Title	Lubiprostone 24mcg Single Dose		Sugar Pill
Arm/Group Description	lubiprostone 24mcg single dose po prior to capsule endoscopy		Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
All Cause Mortality
	Lubiprostone 24mcg Single Dose		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lubiprostone 24mcg Single Dose		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lubiprostone 24mcg Single Dose		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		1/20 (5%)
General disorders
Headache	1/20 (5%)	1	1/20 (5%)	1

Limitations/Caveats

Study participant enrollment met per protocol requirement.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.