Gastric Motility Disorder Clinical Trial
Official title:
Effect of Methylnaltrexone on Gastrointestinal and Colonic Transit in Health
This is a single-center, randomized, double blind, placebo-controlled study evaluating the
effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on
gastrointestinal motility and colonic transit of solids in healthy human subjects.
The hypotheses are:
1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with
acceleration of overall colonic transit, and ascending colon emptying of solids in
healthy humans.
2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine
Methodology
Following the initial screening visit (visit 1), participants will be randomized to study
medication, either 0.30mg/kg methylnaltrexone subcutaneously or placebo once daily and 30 mg
codeine orally or placebo taken four times daily for a total of five days. Participants will
be randomly assigned to study medication and allocation will be concealed. A urine pregnancy
test will be performed for all females of child bearing potential within the 48 hours prior
to the receipt of study medication. Note that females who are status post bilateral tubal
ligation, hysterectomy or postmenopausal are exempted from this test. Study medication will
be administered on study med days 1, 2 and 3 (visits 2, 3 and 4) at the Clinical Research
Unit (CRU). Participants will return for scintigraphic assessment of gastric, small bowel
and colonic transit of solids on study med days 4 and 5 (visits 5 and 6). The transit
studies will be undertaken on over a 48 hour time period; no study medication is given on
the final day of transit (visit 7).
Investigational product, dosage, mode of administration, duration of treatment
0.30 mg/kg methylnaltrexone or placebo subcutaneously once daily and 30 mg codeine or
placebo orally four times daily for five consecutive days.
Treatment groups
1. placebo + placebo (8 participants)
2. placebo + codeine 120mg (8 participants)
3. methylnaltrexone 0.30 mg/kg + placebo (16 participants)
4. methylnaltrexone 0.30 mg/kg + codeine 120 mg (16 participants)
Efficacy assessments
1. Scintigraphic gastrointestinal and colonic transit
2. Assessment of bowel pattern frequency and consistency made by the patient using the
bowel pattern diary
Safety assessments
No safety assessments (routine laboratory analysis, ECG etc) will be performed as both
methylnaltrexone and codeine are FDA approved medications
Statistical analysis
The overall effects of the methylnaltrexone treatment on the primary and secondary response
measures will be assessed using an analysis of covariance (ANCOVA) with suitable
transformation for skewness in the distributions of measured responses if necessary (e.g.,
ANCOVA on ranks or an arcsine square root transformation for the proportion of marker in the
colon at 6 hours). The covariates considered for inclusion in the analyses will be age,
gender and body mass index. An a priori anticipated contrast (overall drug vs. placebo) will
be examined (α = 0.05). The specific comparisons of methylnaltrexone vs placebo and codeine
vs codeine plus methylnaltrexone are of significant interest, and since they are related to
specific hypotheses, no change in α from 0.05 is planned.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05229432 -
Study of Gastric Motility in Eosinophilic Gastritis
|