NCT00240123

Brief Summary

The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Status
withdrawn

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

First QC Date

September 13, 2005

Last Update Submit

September 16, 2015

Conditions

Gallbladder DiseaseGallstonesPancreatitisAbdominal PainJaundice

Keywords

ERCPEUS

Outcome Measures

Primary Outcomes (1)

  • Recovery score

Secondary Outcomes (1)

  • Quality of sedation

Interventions

Benadryl versus PlaceboDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients between 18 and 65 years of age who present for outpatient ERCP or EUS at Strong Memorial Hospital Endoscopy Center will be included

You may not qualify if:

  • Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gallbladder DiseasesGallstonesPancreatitisAbdominal PainJaundice

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPancreatic DiseasesPainNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveHyperbilirubinemiaPathologic ProcessesSkin Manifestations

Study Officials

  • Benedict Maliakkal, MD

    University of Rochester Medical Center, Digestive and Liver Disease Unit

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 17, 2005

Study Start

July 1, 2005

Study Completion

July 1, 2007

Last Updated

September 18, 2015

Record last verified: 2015-09