Trial Outcomes & Findings for Topical Bethanechol for Improvement of Esophageal Dysmotility (NCT NCT01031043)
NCT ID: NCT01031043
Last Updated: 2015-01-29
Results Overview
The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg \*s\*cm to \>10,000 mmHg \*s\*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction.
COMPLETED
PHASE1
5 participants
Encounter 1 (day 1) and Encounter 2 (Month 14)
2015-01-29
Participant Flow
Adult volunteers with a diagnosis of Esophageal Dysmotility were recruited from the senior author's clinical practice.
Participant milestones
| Measure |
Topical Bethanechol
patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
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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|---|---|
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Overall Study
STARTED
|
5
|
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Overall Study
COMPLETED
|
4
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Bethanechol for Improvement of Esophageal Dysmotility
Baseline characteristics by cohort
| Measure |
Topical Bethanechol
n=5 Participants
patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
|
|---|---|
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Age, Continuous
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48 years
STANDARD_DEVIATION 9.8 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Encounter 1 (day 1) and Encounter 2 (Month 14)Population: All subjects enrolled in the study
The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg \*s\*cm to \>10,000 mmHg \*s\*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction.
Outcome measures
| Measure |
Topical Bethanechol
n=5 Participants
patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
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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|---|---|
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Distal Contractile Integral
Baseline Measure
|
178.3 mmHg*s*cm
Standard Deviation 83.1
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Distal Contractile Integral
5 mg dose of Bethanechol
|
272.3 mmHg*s*cm
Standard Deviation 216.9
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Distal Contractile Integral
10 mg dose of Bethanechol
|
261.8 mmHg*s*cm
Standard Deviation 293.5
|
Adverse Events
Topical Bethanechol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place