CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
lubiprostone +1 moredrug
Likely dose
Lubiprostone 24 mcg twice a day for 1 weekAI-extracted
Key inclusion· 4
  • ✓Age 18-65 years
  • ✓For chronic constipation patients: at least 6 months history of constipation defined as fewer than 3 complete spontaneous bowel movements per week plus additional symptoms (hard stools, incomplete evacuation, or straining in ≥25% of bowel movements)
  • ✓For constipation patients ≥50 years: normal colonic anatomy documented by colonoscopy, barium enema, or flexible sigmoidoscopy within previous 5 years
  • ✓Capable of and willing to give informed consent and comply with study requirements
Key exclusion· 12
  • ✕Pregnancy or lactation
  • ✕Unwilling to practice adequate contraception throughout screening and through 14 days after study termination
  • ✕Illegal drug use
  • ✕Regular alcohol consumption of ≥2 drinks per day

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01447849
NCT01447849Phase 3Completed
CompareCT.gov

The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

Texas Tech University Health Sciences Center, El Paso·interventional·Posted Oct 6, 2011·Updated Jun 9, 2017

In Brief

A Phase 3 clinical trial evaluating lubiprostone and placebo for Constipation. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The investigators hypothesize that the symptoms of chronic constipation in some patients are developed due to diminished production and secretion of the alimentary tract mucus resulting in poor lubrication. Therefore, the investigators assume that administration of lubiprostone may restore this lubrication impairment by stimulation of mucus production and secretion within the gastrointestinal tract.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2011
Enrollment StartAug 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.7 years ago

Interventions

lubiprostonedrug

24mcg twice a day (BID) 1 week

placebodrug

Placebo pills twice a day for one week.