NCT00443040

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

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, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 6, 2012

Completed
Last Updated

January 6, 2012

Status Verified

November 1, 2011

Enrollment Period

1.1 years

First QC Date

February 27, 2007

Results QC Date

October 14, 2011

Last Update Submit

November 30, 2011

Conditions

Post-Operative Ileus

Outcome Measures

Primary Outcomes (1)

  • Time to Return of Upper and Lower GI Function

    The time to first bowel movement or the time to tolerating solid food, whichever occurs later.

    Daily for 38 days

Secondary Outcomes (11)

  • Time to Tolerating Solid Food

    4 hours of ingesting a meal

  • Time to First Passage of Flatus

    Daily for 38 days

  • Time to First Bowel Movement

    Daily for 38 days

  • Time to Writing of Hospital Discharge Order

    Daily for 38 days

  • Nausea Score

    Daily for 38 days

  • +6 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Asimadoline 1.0 mg

ACTIVE COMPARATOR

Asimadoline 1.0 mg b.i.d.

Drug: Asimadoline

Asimadoline 3.0 mg

ACTIVE COMPARATOR

Asimadoline 3.0 mg b.i.d.

Drug: Asimadoline

Interventions

AsimadolineDRUG

Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.

Also known as: EMD 61 753, EMR 63 320
Asimadoline 1.0 mgAsimadoline 3.0 mg
PlaceboDRUG

Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-80
  • Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy
  • Must sign an ICF
  • Females of childbearing potential must have a negative pregnancy test at screening

You may not qualify if:

  • Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data
  • Pregnant or breastfeeding females
  • Use of investigational drugs in previous 30 days
  • Refusal to discontinue prohibited concomitant medications
  • Chronic use of prescription narcotics over the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106-5047, United States

Location

Marks Colorectal Surgical Associates

Wynnewood, Pennsylvania, 19096, United States

Location

MeSH Terms

Interventions

asimadoline

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; no efficacy analysis was completed.

Results Point of Contact

Title
Dr. Allen Mangel, Chief Medical Officer
Organization
Tioga Pharmaceuticals
mangel@tiogapharma.com
919-485-5668

Study Officials

  • Allen Mangel, MD, PhD

    CMO

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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 27, 2007

First Posted

March 5, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 6, 2012

Results First Posted

January 6, 2012

Record last verified: 2011-11

Locations

US(4)