NCT01410071

Brief Summary

The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

3.8 years

First QC Date

August 2, 2011

Last Update Submit

August 3, 2011

Conditions

Sphincter of Oddi DysfunctionAbdominal Pain

Keywords

Sphincter of Oddi Dysfunction

Outcome Measures

Primary Outcomes (1)

  • symptom improvement

    one year

Secondary Outcomes (1)

  • improved quality of life

    one year

Study Arms (1)

sphincter of oddi dysfunction

endoscopic therapy vs conservative care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

physician's private practice/clinic patients presenting with suspected sphincter of oddi dysfunction

You may qualify if:

  • over age 18
  • suspected history and clinical features suggestive of sphincter of oddi dysfunction

You may not qualify if:

  • prior history of endoscopic therapy for sphincter of oddi dysfunction
  • no proven sphincter of oddi dysfunction on manometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53151, United States

Location

MeSH Terms

Conditions

Sphincter of Oddi DysfunctionAbdominal Pain

Condition Hierarchy (Ancestors)

Biliary DyskinesiaCommon Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Nalini M Guda, MD

    GI Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

September 1, 2005

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

US(1)