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CompletedNCT02576340Updated Oct 15, 2015

Spasmolytic in Upper Gastrointestinal Endoscopy

A Phase 4 interventional study of otilonium bromide in Gastroscopy, sponsored by Konya Meram State Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by Konya Meram State Hospital · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastroscopy
03

In context

Lead sponsor

Konya Meram State Hospital is the lead sponsor of 45 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • no hypersensitivity to the agent.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
400 participants (actual)

Study arms

  • Active comparator
    study

    drug was administered

    Drug: otilonium bromide

  • No intervention
    control

    no drug administered

Interventions

  • Drugotilonium bromide

    otilonium bromide was administered before the procedure

06

What researchers measure

Primary outcomes

  1. motility

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

    Time frame: 3 months

Secondary outcomes

  1. patient tolerance

    patient tolerance will be determined by questionnaire

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02576340
Lead sponsor
Konya Meram State Hospital
Responsible party
barış sevinç (M. D., Konya Meram State Hospital) — Principal investigator
First posted
Oct 15, 2015
Start date
Jan 2013
Primary completion
May 2013
Completion
Jun 2013
Last update
Oct 15, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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