The Effectiveness of Lubiprostone in Constipated Diabetics

NCT01170039 | Completed Phase 4 Results

• 1 other identifier: IRB00014592
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators will recruit a total of 136 diabetic men and women with constipation into this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours after initiation of study drug (SBMs) in all patients two weeks before treatment with lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule. Colon transit reflects that rate of colonic peristalsis and movement of stool through the large bowel. Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will over-sample African American patients to achieve approximately 50% enrollment of this group. In a subanalysis, the investigators will assess response to treatment between the general population and African Americans. We hypothesize that lubiprostone will significantly increase the number of SBMs as well as decrease colonic transit time and improve quality of life in constipated diabetic patients compared with placebo.

Conditions

Constipation; Diabetes

Keywords

Constipation; Diabetes; Lubiprostone; Amitiza; African Americans

Outcome Measures

Primary Outcomes (1)

• Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week

  The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.

  1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks

Secondary Outcomes (3)

• Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule

  Baseline, 4 weeks

• Number of Subjects With Daily Abdominal Discomfort

  1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks

• Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire

  Screening, 8 weeks

Study Arms (2)

Lubiprostone

ACTIVE COMPARATOR

Drug: Lubiprostone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lubiprostone DRUG

Lubiprostone will be given as 24 mcg orally twice a day.

Also known as: Amitiza

Lubiprostone

Placebo DRUG

A matched placebo pill will be given twice a day for 8 weeks.

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients with constipation.
• Patient must be on stable oral or subcutaneous hypoglycemic medication for 6 months.

You may not qualify if:

• Acute infections
• Ischemic bowel syndrome
• Gastrointestinal obstruction

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Atlanta Veterans Administration Hospital

Atlanta, Georgia, 30033, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Constipation; Diabetes Mellitus

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jennifer Christie
• Organization: Emory University

jchris6@emory.edu

404-778-4594

Study Officials

• Jennifer A Christie, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Latoya Carter

  Emory University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 15, 2016
• Results First Posted: March 15, 2016

Record last verified: 2016-02

Locations

US (2)