- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576340
Spasmolytic in Upper Gastrointestinal Endoscopy
October 14, 2015 updated by: barış sevinç, Konya Meram State Hospital
Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: study
drug was administered
|
otilonium bromide was administered before the procedure
|
No Intervention: control
no drug administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motility
Time Frame: 3 months
|
decrease in motility during the procedure (number of peristaltic moves in a minute)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient tolerance
Time Frame: 3 months
|
patient tolerance will be determined by questionnaire
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
October 12, 2015
First Submitted That Met QC Criteria
October 14, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
October 14, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Gastrointestinal Agents
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Bromides
- Octylonium
Other Study ID Numbers
- ob002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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