Phase 4
N=5
Study of Metoclopramide in Small Bowel Capsule Endoscopy
Pill Capsule Endoscopy Completion Rates
Bottom Line
View on ClinicalTrials.gov: NCT01630109 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Difference in Treatment vs. Placebo in Pill Capsule Completion Rates — 100; 0; 100 percentage of complete capsule studies
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metoclopramide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ascension Health
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Treatment vs. Placebo in Pill Capsule Completion Rates |
100; 0; 100 | — |
| SECONDARY Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies |
15; 57; 88 | — |
| SECONDARY Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies |
53; 218; 301 | — |
| SECONDARY Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics |
100; 100; 0; 100 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01630109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.