NCT01993875

Brief Summary

To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

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

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
6 years until next milestone

Results Posted

Study results publicly available

December 13, 2019

Completed
Last Updated

December 13, 2019

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

November 19, 2013

Results QC Date

October 14, 2019

Last Update Submit

November 26, 2019

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

  • Number of Spontaneous Bowel Movements (SBMs) Within 1 Week

    SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.

    within 1 week

Secondary Outcomes (5)

  • Consistency of SBMs at Week 1

    at Week 1

  • Overall Stool Consistency at Week 1

    at Week 1

  • Mean Change From Baseline in Stool Consistency at Week 1

    Baseline and Week 1

  • Overall Straining at Week 1

    Week 1

  • Mean Change From Baseline in Straining at Week 1

    Week 1

Study Arms (2)

Lubiprostone

EXPERIMENTAL
Drug: Lubiprostone

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LubiprostoneDRUG

Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)

Lubiprostone
PlaceboDRUG

Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)

Placebo

Eligibility Criteria

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

You may qualify if:

  • Medically-confirmed diagnosis of chronic idiopathic constipation
  • Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
  • Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

You may not qualify if:

  • Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
  • Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Anniston, Alabama, 36207, United States

Location

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

DeLand, Florida, 32720, United States

Location

Unknown Facility

Hollywood, Florida, 33024, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Overland Park, Kansas, 66212, United States

Location

Unknown Facility

Marlton, New Jersey, 08053, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Salt Lake City, Utah, 84106, United States

Location

Unknown Facility

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

AlprostadilFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Results Point of Contact

Title
Medical Information Call Center
Organization
Mallinckrodt
clinicaltrials@mnk.com
800-556-3314

Study Officials

  • Global Clinical Leader

    Mallinckrodt

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 13, 2019

Results First Posted

December 13, 2019

Record last verified: 2015-07

Data Sharing

IPD Sharing
Will not share

Locations

US(11)