NCT01301781

Brief Summary

A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

4 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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

4 months

First QC Date

February 22, 2011

Last Update Submit

September 27, 2012

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose

    3 hours

Secondary Outcomes (2)

  • percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose

    3 hours

  • serum chemistry

    7 days

Study Arms (2)

BLI801 laxative

EXPERIMENTAL

BLI801 laxative - oral solution

Drug: BLI801

Placebo

PLACEBO COMPARATOR

BLI801 placebo - oral solution

Drug: Placebo

Interventions

BLI801DRUG

BLI801 laxative - oral solution

BLI801 laxative
PlaceboDRUG

BLI801 placebo - oral solution

Placebo

Eligibility Criteria

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

You may qualify if:

  • Constipated, defined by ROME III definition
  • Subject has \< 3 satisfactory BMs during the run-in period

You may not qualify if:

  • Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
  • Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments.
  • Subjects who are allergic to any BLI801 component
  • Subjects taking narcotic analgesics or other medications known to cause constipation.
  • Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
  • Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
  • Subjects with an active history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Jupiter Research

Jupiter, Florida, 33458, United States

Location

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Long Island GI Research Group

Great Neck, New York, 11023, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Last Updated

October 1, 2012

Record last verified: 2012-09

Locations

US(4)