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

NCT01096290 | Terminated Phase 4 Results DMC

• 1 other identifier: 09-250
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

constipation; lubiprostone; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Relief of Constipation Defined by Modified ROME Criteria

  Subjects will report symptoms by questionnaire

  30 days

Secondary Outcomes (1)

• Frequency

  30 days

Study Arms (2)

Lubiprostone 24mcg BID for 30 days

EXPERIMENTAL

Active medication

Drug: lubiprostone

Placebo

PLACEBO COMPARATOR

Placebo, matched, blinded

Drug: Matched placebo

Interventions

lubiprostone DRUG

24mcg BID, capsule, oral 30days

Also known as: Amitiza

Lubiprostone 24mcg BID for 30 days

Matched placebo DRUG

Twice daily for 30days, oral

Also known as: Placebo, sugar pill

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female outpatient age 19 or older.
• Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation\*:
• Must include two or more of the following:
• Straining in \> 1/4 defecations;
• Lumpy or hard stools \> 1/4 defecations;
• Sensation of incomplete evacuation in 1/4 defecations;
• Sensation of anorectal obstruction/blockage in \> 1/4 defecations;
• \<3 defecations/week.
• Loose stools are rarely present without the use of laxatives.
• 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.
• Study subjects must not have received lubiprostone for more than 72 hours.
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Alabama: lead
• Takeda: collaborator
• Sucampo Pharmaceuticals, Inc.: collaborator

Study Sites (1)

USA Pavilion at Infirmary West

Mobile, Alabama, 36693, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone; Sugars

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; Carbohydrates

Limitations and 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.

Results Point of Contact

• Title: Jack DiPalma, MD
• Organization: University of South Alabama

jdipalma@health.southalabama.edu

251-660-5555

Study Officials

• Jack A DiPalma, M.D.

  University of South Alabama College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 31, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 20, 2020
• Results First Posted: September 9, 2020

Record last verified: 2020-11

Locations

US (1)