NCT01297608

Brief Summary

This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

February 15, 2011

Last Update Submit

December 11, 2013

Conditions

Fecal Incontinenece

Outcome Measures

Primary Outcomes (1)

  • fecal incontinence

    2 weeks

Secondary Outcomes (1)

  • quality of life

    2 weeks

Study Arms (2)

treatment

EXPERIMENTAL
Drug: caoted suppositoryDrug: coated suppository

placebo

PLACEBO COMPARATOR
Drug: coated suppository

Interventions

caoted suppositoryDRUG

coated suppository with active drug

treatment
coated suppositoryDRUG

coated suppository with placebo

placebotreatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Signed written informed consent; Male or female subjects 18 to 55 years of age; Spinal cord lesion/disease/injury at any level at least 3 months from injury. FISI (Fecal Incontinence Severity Index) \> 8 units. The patient is able to understand the treatment and is willing to comply with the prescribed regimen

You may not qualify if:

  • Known allergy to experimental drug..
  • Porphiria.
  • Glaucoma.
  • Pregnancy or lactation.
  • Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
  • Type 1 diabetes mellitus;
  • Insulin treated type 2 diabetes mellitus.
  • Renal insufficiency.
  • Liver insufficiency.
  • Malignant disease within 5 years of screening;
  • Has hypertension (sitting blood pressure \> 140/90 mmHg at screening)
  • History of rectal surgery.
  • History of HIV, hepatitis B, hepatitis.
  • Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
  • Use of tricyclic or monoamine-oxidase inhibors.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroeneterology dept, Asaf harofe Medical center

Zrifin, Israel

Location
0

Study Design

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

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 17, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

IL(1)