NCT02576340

Brief Summary

Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase the tolerability and compliance of the patient, sedation is applied. There are many studies showing that sedation increases the patient compliance and the tolerability. However, spasmolytic use in GE has not been evaluated yet.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

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

January 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

October 12, 2015

Last Update Submit

October 14, 2015

Conditions

Gastroscopy

Outcome Measures

Primary Outcomes (1)

  • motility

    decrease in motility during the procedure (number of peristaltic moves in a minute)

    3 months

Secondary Outcomes (1)

  • patient tolerance

    3 months

Study Arms (2)

study

ACTIVE COMPARATOR

drug was administered

Drug: otilonium bromide

control

NO INTERVENTION

no drug administered

Interventions

otilonium bromideDRUG

otilonium bromide was administered before the procedure

study

Eligibility Criteria

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

You may qualify if:

  • no hypersensitivity to the agent.

You may not qualify if:

  • Emergent cases,the cases with low mental compatibility and pregnant women were excluded from the study. Moreover, the procedures under sedation, cases with disorders decreasing the intestinal motility like hypothyroidism and diabetes were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

octylonium

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. D.

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 15, 2015

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

October 15, 2015

Record last verified: 2015-10