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The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.
As mentioned above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide | Experimental | All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide | Drug | Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH). Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes. | Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide. |
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Inclusion Criteria:
Exclusion Criteria:
• Subjects with known or suspected allergy to octreotide.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Croffie | Riley Hospital for Children | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children, | Indianapolis | Indiana | 46202 | United States |
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All eligible patients referred for colonic manometry to the GI Motility Laboratory at Riley Hospital between Sep 2013 and June 2014.
24 patients were assessed for eligibility to participate in the study in the hospital. 8 patients were excluded, as they did not meet inclusion criteria. 3 participant refused enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Octreotide | This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Octreotide |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH). Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes. | Posted | Mean | 95% Confidence Interval | mm Hg | Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild discomfort with administration of subcutaneous octreotide | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Croffie | Riley Hospital for Children, Indiana University | 317-944-3774 | jcroffie@iupui.edu |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Bisacodyl | Drug |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| 15 Minutes |
The MI for the 15 minutes before and after octreotide infusion was measured. |
| OG001 | 30 Minutes | The MI for the 30 minutes before and after octreotide infusion was measured. |
| OG002 | 45 Minutes | The MI for the 45 minutes before and after octreotide infusion was measured. |
|
|
|
| 0 |
| 13 |
| 7 |
| 13 |
| mild abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |