Pill Capsule Endoscopy Completion Rates
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMetoclopramide
A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.
DRUGPlacebo
A placebo capsule made to look like the metoclopramide capsule.
Sponsors
Ascension Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women over the age of 18 undergoing pill capsule endoscopy to investigate unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel habits, and/or weight loss.
Exclusion criteria
* Inability to sign consent for research participation * Inability to swallow PillCam™, placebo, or metoclopramide capsule * Known hypersensitivity/allergy to metoclopramide * Active congestive heart failure or respiratory failure requiring ventilator assistance * Presence of cardiac pacemaker or implanted electromedical device * Known bowel obstruction/stricture/fistula or intrauterine pregnancy * Known history of Whipple procedure (pancreaticoduodenectomy), Billroth II surgery (partial gastrectomy with gastrojejunostomy), or gastric bypass surgery due to risk of capsule retention in a blind intestinal limb necessitating surgical retrieval * Known history of seizure disorder, renal failure requiring dialysis, or pheochromocytoma * Lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | 12 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 12 hours | This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time. |
| Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 12 hours | 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. |
| Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | 12 hours | 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. |
Countries
United States
Participant flow
Recruitment details
Study subjects were recruited from December 2012 to June 2013. The subjects were recruited in the Medical Procedures Unit at Genesys Regional Medical Center.
Pre-assignment details
No events to report.
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide 5 mg Pro-motility agent | 1 |
| Metoclopramide 10 mg Pro-motility agent | 1 |
| Placebo Control Placebo to be used as the control group | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Metoclopramide 10 mg | Placebo Control | Metoclopramide 5 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 0 | 46 years STANDARD_DEVIATION 12.76 | 54 years STANDARD_DEVIATION 0 | 50.20 years STANDARD_DEVIATION 10.84 |
| Region of Enrollment United States | 1 participants | 3 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 3 |
Outcome results
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).
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metoclopramide 5 mg | Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | 100 percentage of complete capsule studies |
| Metoclopramide 10 mg | Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | 0 percentage of complete capsule studies |
| Placebo Control | Difference in Treatment vs. Placebo in Pill Capsule Completion Rates | 100 percentage of complete capsule studies |
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.
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Control | Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | 100 Percentage of complete studies |
| Metoclopramide 5 mg (Non-diabetic) | Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | 100 Percentage of complete studies |
| Metoclopramide 10 mg (Non-diabetic) | Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | 0 Percentage of complete studies |
| Placebo (Non-diabetic) | Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics | 100 Percentage of complete studies |
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.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide 5 mg | Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 15 minutes | Standard Deviation 0 |
| Metoclopramide 10 mg | Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 57 minutes | Standard Deviation 0 |
| Placebo Control | Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 88 minutes | Standard Deviation 106.12 |
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.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide 5 mg | Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 53 minutes | Standard Deviation 0 |
| Metoclopramide 10 mg | Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 218 minutes | Standard Deviation 0 |
| Placebo Control | Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies | 301 minutes | Standard Deviation 114.45 |