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NCT02576340 Clinical Trial

Spasmolytic in Upper Gastrointestinal Endoscopy

Gastroscopy Clinical Trial

Official title:
Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02576340
Other study ID # ob002
Secondary ID
Status Completed
Phase Phase 4
First received October 12, 2015
Last updated October 14, 2015
Start date January 2013
Est. completion date June 2013

Study information
Verified date October 2015
Source Konya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date June 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- no hypersensitivity to the agent.

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• otilonium bromide
otilonium bromide was administered before the procedure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Konya Training and Research Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary motility decrease in motility during the procedure (number of peristaltic moves in a minute) 3 months No
Secondary patient tolerance patient tolerance will be determined by questionnaire 3 months No
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