NCT01460225

Brief Summary

This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

July 13, 2018

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

July 19, 2010

Results QC Date

April 3, 2018

Last Update Submit

July 12, 2018

Conditions

Chronic Idiopathic Constipation

Keywords

constipationchronic idiopathic constipationno prior history of surgery to the colonnot on any type of medication that could alter gastrointestinal motility or transit

Outcome Measures

Primary Outcomes (1)

  • Gastric Emptying

    gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)

    Day 1 and Day 7

Study Arms (1)

Treatment

EXPERIMENTAL

24 micrograms of lubiprostone twice daily for one week.

Drug: lubiprostone

Interventions

lubiprostoneDRUG

24 micrograms twice daily for 1 week

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic idiopathic constipation

You may not qualify if:

  • medications that slow gastrointestinal (GI) motility
  • prior surgery to the GI tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlprostadilFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Results Point of Contact

Title
Dr. Brian Lacy
Organization
Dartmouth-Hitchcock Medical Center
brian.e.lacy@hitchcock.org
603-650-5215

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2010

First Posted

October 26, 2011

Study Start

September 1, 2007

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

July 13, 2018

Results First Posted

July 13, 2018

Record last verified: 2018-07

Locations

US(1)