Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

• Sponsor: University of South Alabama (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01096290
• Collaborator: Takeda (Industry), Sucampo Pharmaceuticals, Inc. (Industry)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: lubiprostone; Drug: Matched placebo	Phase 4

Detailed Description

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 and recently, constipation-predominant irritable bowel syndrome.

The Physicians Desk Reference lists over 90 Brand medications with reported incidence associated with constipation over 3%. Little data are available about treatment responses. A recent publication by our group reported treatment success for medication constipation using polyethylene glycol. Since ongoing studies are addressing the role of lubiprostone in opioid constipation, this work will be enrolling medication constipation study subjects not using opioids.

In this study, patients who meet diagnostic criteria for constipation will be randomized to receive 28 days of treatment with lubiprostone 24mcg twice a day. Data will be collected to evaluate therapeutic outcome.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lubiprostone 24mcg BID for 30 days Active medication	Drug: lubiprostone; 24mcg BID, capsule, oral 30days; Other Names: Amitiza
Placebo Comparator: Placebo Placebo, matched, blinded	Drug: Matched placebo; Twice daily for 30days, oral; Other Names: Placebo, sugar pill

Outcome Measures

Primary Outcome Measures

1. Relief of Constipation Defined by Modified ROME Criteria [30 days]

   Subjects will report symptoms by questionnaire

Secondary Outcome Measures

1. Frequency [30 days]

   Subjects will report stool frequency by questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult male or female outpatient age 19 or older.

• Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:

1. Must include two or more of the following:

2. Straining in > 1/4 defecations;

3. Lumpy or hard stools > 1/4 defecations;

4. Sensation of incomplete evacuation in 1/4 defecations;

5. Sensation of anorectal obstruction/blockage in > 1/4 defecations;

6. <3 defecations/week.

7. Loose stools are rarely present without the use of laxatives.

8. There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

• Use of one or more of listed medications known to cause constipation.

• If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study. Mandatory compliance is required. Serum pregnancy tests will be performed at screening and during needed follow-up. Negative results will be received before inclusion and administration of first study dose. If pregnancy occurs during the trial, the investigator is notified immediately resulting in prompt discontinuation.

• Study subjects must not have received lubiprostone for more than 72 hours.

• Written informed consent.

Exclusion Criteria:

• Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.

• Severe diarrhea.

• Prior small bowel or colonic resection or colostomy.

• Weight < 80 lbs.

• If the patient has constipation that according to the investigator's clinical judgment is not the result of constipating medications but is suffering from a secondary cause including but limited to factors that are dietary, neurologic, congenital, diabetic or hypothyroid.

• Positive stool hemoccult (Can be included if colonoscopic evaluation is subsequently negative).

• Significant cardiac, renal or hepatic insufficiency.

• Pregnant or expecting to become pregnant within 120 days of study enrollment.

• Lactating or breast feeding.

• Subjects using opioid medications.

• Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.

• Use of investigational drugs in the last 30 days.

• Patients with known allergy to lubiprostone.

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, M.D., University of South Alabama College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Alabama
• ClinicalTrials.gov Identifier: NCT01096290
• Other Study ID Numbers: 09-250
• First Posted: Mar 31, 2010
• Last Update Posted: Nov 20, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by University of South Alabama: constipation; lubiprostone; healthy volunteers
• Additional relevant MeSH terms: Constipation; Lubiprostone

Study Results

Participant Flow

Arm/Group Title	Lubiprostone 24mcg BID for 30 Days	Placebo
Arm/Group Description	Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral
Period Title: Overall Study
STARTED	9	14
COMPLETED	9	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lubiprostone 24mcg BID for 30 Days	Placebo	Total
Arm/Group Description	Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral	Total of all reporting groups
Overall Participants	9	14	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 88.9%	12 85.7%	20 87%
>=65 years	1 11.1%	2 14.3%	3 13%
Sex: Female, Male (Count of Participants)
Female	7 77.8%	8 57.1%	15 65.2%
Male	2 22.2%	6 42.9%	8 34.8%

Outcome Measures

1. Primary Outcome

Title	Relief of Constipation Defined by Modified ROME Criteria
Description	Subjects will report symptoms by questionnaire
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lubiprostone 24mcg BID for 30 Days	Placebo
Arm/Group Description	Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral
Measure Participants	9	14
Count of Participants [Participants]	7 77.8%	7 50%

2. Secondary Outcome

Title	Frequency
Description	Subjects will report stool frequency by questionnaire
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Data was not collected for this Outcome Measure

Arm/Group Title	Lubiprostone 24mcg BID for 30 Days	Placebo
Arm/Group Description	Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral
Measure Participants	0	0

Adverse Events

Time Frame	From screening visit 1 to Follow-up Day 56
Arm/Group Title	Lubiprostone 24mcg BID for 30 Days		Placebo
Arm/Group Description	Active medication lubiprostone: 24mcg BID, capsule, oral 30days		Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral
All Cause Mortality
	Lubiprostone 24mcg BID for 30 Days		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/14 (0%)
Serious Adverse Events
	Lubiprostone 24mcg BID for 30 Days		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Lubiprostone 24mcg BID for 30 Days		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/14 (0%)

Limitations/Caveats

100 participants were needed to obtain statistical power. Only 23 participants were enrolled. Therefore, data analysis was not completed since a success rate could not be adequately demonstrated on such a small sample.

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.