Phase 4
N=48
Effect of Methylnaltrexone on GI Transit in Healthy Volunteers
Gastric Motility Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01055704 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Colonic Geometric Center at 24 Hours — 2.3; 1.8; 1.9; 2.3 Units on a scale — p=0.902
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylnaltrexone only (Drug); Codeine only (Drug); Methylnaltrexone + codeine (Drug); Placebo + placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colonic Geometric Center at 24 Hours |
2.3; 1.8; 1.9; 2.3 | 0.902 |
| SECONDARY T1/2 of Ascending Colon Emptying |
17.1; 24.0; 23.6; 14.1 | 0.675 |
| SECONDARY T1/2 of Gastric Emptying of Solid |
102.7; 104.0; 126.8; 101.1 | 0.024 sig |
| SECONDARY Colonic Geometric Center at 4 Hours |
0.236; 0; 0.379; 0.347 | 0.064 |
| SECONDARY Colonic Geometric Center at 48 Hours |
3.9; 3.3; 2.8; 4.1 | 0.151 |
| SECONDARY Colonic Filling at 6 Hours |
21.9; 23.7; 28.0; 34.5 | 0.889 |
| SECONDARY Stool Frequency |
1.1; 0.63; 0.7; 1.5 | 0.236 |
| SECONDARY Stool Consistency as Reported From the Bristol Stool Scale |
3.4; 3.1; 3.3; 3.7 | 0.192 |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant, non-breastfeeding females
- 18-65 years old
- No functional GI disorders on the short Bowel Disease Questionnaire (BDQ)
- A BMI greater than 22.0
Exclusion criteria
- Structural or metabolic diseases/conditions that affect the gastrointestinal system or functional gastrointestinal disorders. The short version of the Bowel Disease Questionnaire (BDQ) will be exclude functional GI disorders. More than three positive responses will exclude participation.
- Unable to withdraw from the following medications 48 hours prior to study entry:Any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants; analgesic drugs including opiates, NSAID, COX 2 inhibitors (note : Tylenol is permitted); GABAergic agents and benzodiazepines. Note: Concomitant medications will be reviewed on a case by case basis by the study physicians.
- Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers. Alcohol must be avoided from seven days prior to beginning the study medication until the completion of the study.
- Subjects who have participated in another clinical study within the past 30 days.
- Clinical evidence (including physical exam and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
Data sourced from ClinicalTrials.gov (NCT01055704). 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.