Topical Bethanechol for Improvement of Esophageal Dysmotility
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Georgia Regents University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Georgia Regents University
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01031043
First received: December 10, 2009
Last updated: May 12, 2011
Last verified: May 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 10, 2009 | ||||||||
| Last Updated Date | May 12, 2011 | ||||||||
| Start Date ICMJE | November 2009 | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hypothesis is that topically applied bethanechol will improve esophageal smooth muscle contractility and bolus transit in patients with severe IEM. [ Time Frame: The study will involve 1 visit, which will last approximately 45 minutes. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01031043 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Topical Bethanechol for Improvement of Esophageal Dysmotility | ||||||||
| Official Title ICMJE | Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study | ||||||||
| Brief Summary | The purpose of this research project is to determine the effect of a drug called bethanechol on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is FDA approved for use in treating other conditions, but not for the treatment of IEM. There is currently no approved therapy for the treatment of IEM. This information is important for the possible development of new ways of treating patients with IEM and for the effectiveness of topically applied Bethanechol on patients with IEM. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ineffective Esophageal Motility | ||||||||
| Intervention ICMJE | Drug: Bethanechol
Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | April 2012 | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01031043 | ||||||||
| Other Study ID Numbers ICMJE | 09-03-244 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Gregory Postma, MD, Medical College of Georgia | ||||||||
| Study Sponsor ICMJE | Georgia Regents University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Georgia Regents University | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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