A Phase 4 interventional study of Metoclopramide and Placebo in Pill Capsule Endoscopy Completion Rates, sponsored by Ascension Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-27.
Sponsored by Ascension Health · Phase 4 and Interventional
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.
Ascension Health is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pro-motility agent
Drug: Metoclopramide
Pro-motility agent
Drug: Metoclopramide
Placebo to be used as the control group
Drug: Placebo
A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.
Also known as: Brand name of Metoclopramide is Reglan
A placebo capsule made to look like the metoclopramide capsule.
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).
Time frame: 12 hours
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.
Time frame: 12 hours
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.
Time frame: 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.
Time frame: 12 hours
Study subjects were recruited from December 2012 to June 2013. The subjects were recruited in the Medical Procedures Unit at Genesys Regional Medical Center.
| Milestone | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control |
|---|---|---|---|
| Started | 1 | 1 | 3 |
| Completed | 1 | 1 | 3 |
| Not completed | 0 | 0 | 0 |
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).
| percentage of complete capsule studies | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control |
|---|---|---|---|
| Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | 100 | 0 | 100 |
This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.
| minutes | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control |
|---|---|---|---|
| Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 15 ± 0 | 57 ± 0 | 88 ± 106.12 |
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.
| minutes | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control |
|---|---|---|---|
| Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 53 ± 0 | 218 ± 0 | 301 ± 114.45 |
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.
| Percentage of complete studies | Metoclopramide 5 mg (Diabetics) | Metoclopramide 10 mg (Diabetics) | Placebo Control (Diabetics) | Metoclopramide 5 mg (Non-diabetic) | Metoclopramide 10 mg (Non-diabetic) | Placebo (Non-diabetic) |
|---|---|---|---|---|---|---|
| Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | — | — | 100 | 100 | 0 | 100 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metoclopramide 5 mg | — | 0/1 (0%) | 0/1 (0%) |
| Metoclopramide 10 mg | — | 0/1 (0%) | 0/1 (0%) |
| Placebo Control | — | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 3 | 5 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control | Total |
|---|---|---|---|---|
| Mean | 54 ± 0 | 59 ± 0 | 46 ± 12.76 | 50.20 ± 10.84 |
| Sex: Female, Male(Participants) | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 2 | 2 |
| Male | 1 | 1 | 1 | 3 |
| Region of Enrollment(participants) | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control | Total |
|---|---|---|---|---|
| United States | 1 | 1 | 3 | 5 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Ascension Health