The Effectiveness of Lubiprostone in Constipated Diabetics
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
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.