NCT02716025

Brief Summary

Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done for all the included patients in addition to twenty five age and sex matched healthy control subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 17, 2016

Last Update Submit

March 21, 2016

Conditions

Peptic Ulcer Disease

Outcome Measures

Primary Outcomes (1)

  • Detection of positive upper GIT endoscopic findings

    upon endoscopy

Study Arms (2)

Case Group

Procedure: Upper gastrointestinal endoscopy

Control Group

Interventions

Upper gastrointestinal endoscopyPROCEDURE

Thorough examination of the esophagus, stomach and duodenum to the second part was done to all patients using Olympus CV-150 or Pentax EPM-3500.

Case Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn who were candidates for upper gastrointestinal endoscopy.

You may qualify if:

  • Symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn

You may not qualify if:

  • Patients who received zinc supplementation, proton pump inhibitors (PPI), non-steroidal anti-inflammatory drugs (NSAIDs)
  • Those presented with hematemesis or melena
  • Those with chronic liver disease, renal failure, malabsorption or previous gastric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 22, 2016

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03