Effect of Methylnaltrexone on GI Transit in Healthy Volunteers
NCT01055704
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- 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
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Effect of Methylnaltrexone on GI Transit in Healthy Volunteers | |||
Official Title ICMJE | Effect of Methylnaltrexone on Gastrointestinal and Colonic Transit in Health | |||
Brief 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:
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Detailed Description | 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
Efficacy assessments
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 (? = 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 ? from 0.05 is planned. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Gastric Motility Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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 Pharmacol Ther. 2010 Oct;32(7):884-93. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 48 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2010 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01055704 | |||
Other Study ID Numbers ICMJE | 09-002996 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Michael Camilleri, MD, Mayo Clinic | |||
Study Sponsor ICMJE | Mayo Clinic | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Mayo Clinic | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |