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
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Wong BS, Rao AS, Camilleri M, Manabe N, McKinzie S, Busciglio I, Burton DD, Ryks M, Zinsmeister AR. The effects of methylnaltrexone alone and in combination with acutely administered codeine on gastrointestinal and colonic transit in health. Aliment Pharm — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Colonic Geometric Center at 24 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | 24 hours | No |
Secondary | T1/2 of Ascending Colon Emptying | 24 hours | No | |
Secondary | T1/2 of Gastric Emptying of Solid | 4 hours | No | |
Secondary | Colonic Geometric Center at 4 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | 4 hours | No |
Secondary | Colonic Geometric Center at 48 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | 48 hours | No |
Secondary | Colonic Filling at 6 Hours | Percent of solids reaching the colon at 6 hours | 6 hours | No |
Secondary | Stool Frequency | Stool frequency was self reported in a daily bowel pattern diary for 13 days. | daily | No |
Secondary | Stool Consistency as Reported From the Bristol Stool Scale | Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea. | Daily | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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