NCT00213460

Brief Summary

Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death. In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc. The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

First QC Date

September 13, 2005

Last Update Submit

April 15, 2013

Conditions

Systemic Sclerosis

Eligibility Criteria

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

You may qualify if:

  • patients with systemic sclerosis, who had an upper intestinal tract manometry 5 years before, with:
  • age over 18 years
  • written informed consent

You may not qualify if:

  • pregant women
  • patients with psychiatric conditions
  • unwritten informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rouen

Rouen, Rouen Cedex, 76031, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Isabelle MARIE, MD, PhD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2001

Study Completion

July 1, 2003

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

FR(1)