Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design. The outcomes to be assessed are capsule study completion rates, gastric transit time, small bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel transit time, and pill capsule completion rates in diabetes.
Pill Capsule Endoscopy allows Gastroenterologists to visualize the mucosa of the small bowel beyond the reach of any endoscope and to an extent never before possible. It involves the ingestion of a small pill camera approximately the size of a large vitamin. 8 hours of images are transmitted to a sensor worn around the patient's waist. At the conclusion of the test, these images are downloaded to a computer for physician review. Meanwhile, the PillCam™ passes naturally through the digestive system and does not require retrieval.
Many of these pill capsule studies are incomplete due to failure of the pill capsule to reach the colon. Metoclopramide (brand name Reglan) is an anti-emetic that also has known pro-motility effects in the GI tract. The thought behind this study is that metoclopramide will increase the rate of passage of the pill capsule through the GI tract allowing a higher completion rate of the pill capsule studies.
Patients scheduled for pill capsule endoscopy will be approached on the morning of their procedure to inform them of the research study. After proper consent is obtained the patient will receive either 5 mg Metoclopramide, 10 mg Metoclopramide, or a placebo pill 30 minutes prior to their pill capsule study. The pill capsule camera records 8 hours worth of data. The patient will return at the conclusion of their study to turn in their recorder. The ordering gastroenterologist will then read the study. Information regarding pill capsule completion (pill capsule goes through the ileocecal valve), gastric transit time, and small bowel transit time will then be recorded and analyzed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide 5 mg | Active Comparator | Pro-motility agent |
|
| Metoclopramide 10 mg | Active Comparator | Pro-motility agent |
|
| Placebo control | Placebo Comparator | Placebo to be used as the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg). | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time. | 12 hours |
| Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven D Brooks, D.O. | Ascension Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
No events to report.
Study subjects were recruited from December 2012 to June 2013. The subjects were recruited in the Medical Procedures Unit at Genesys Regional Medical Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide 5 mg | Pro-motility agent |
| FG001 | Metoclopramide 10 mg | Pro-motility agent |
| FG002 | Placebo Control | Placebo to be used as the control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide 5 mg | Pro-motility agent |
| BG001 | Metoclopramide 10 mg | Pro-motility agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg). | Posted | Number | percentage of complete capsule studies | 12 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metoclopramide 5 mg | Pro-motility agent |
Not provided
Not provided
The main limitation of this study was that there was a lower number of capsule studies performed at the study center than anticipated so it was difficult to find patients to enroll.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Brooks | Genesys Regional Medical Center Office of Research | 8106067722 | Steven.Brooks@genesys.org |
Not provided
| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | A placebo capsule made to look like the metoclopramide capsule. |
|
This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo. |
| 12 hours |
| Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic. | 12 hours |
| BG002 |
| Placebo Control |
Placebo to be used as the control group |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo to be used as the control group |
|
|
| Secondary | Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time. | Posted | Mean | Standard Deviation | minutes | 12 hours |
|
|
|
| Secondary | Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies | This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo. | Posted | Mean | Standard Deviation | minutes | 12 hours |
|
|
|
| Secondary | Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic. | Posted | Number | Percentage of complete studies | 12 hours |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Metoclopramide 10 mg | Pro-motility agent | 0 | 1 | 0 | 1 |
| EG002 | Placebo Control | Placebo to be used as the control group | 0 | 3 | 0 | 3 |
Not provided
Not provided
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |