Effect of Methylnaltrexone on GI Transit in Healthy Volunteers

NCT01055704

Last updated date
Study Location
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastric Motility Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Gastric Motility DisorderEffect of Methylnaltrexone on GI Transit in Healthy Volunteers
NCT01055704
  1. Rochester, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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:

  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
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

  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 (? = 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
  • Drug: Methylnaltrexone only
    0.30 mg/kg subcutaneous injection daily
    Other Names:
    • MNTX
    • Relistor
  • Drug: Codeine only
    30 mg taken orally four times daily for 5 days
  • Drug: Methylnaltrexone + codeine
    Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days
  • Drug: Placebo + placebo
    Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days
Study Arms  ICMJE
  • Experimental: Methylnaltrexone
    Intervention: Drug: Methylnaltrexone only
  • Experimental: Codeine
    Intervention: Drug: Codeine only
  • Experimental: Methylnaltrexone + codeine
    Intervention: Drug: Methylnaltrexone + codeine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo + placebo
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
 (submitted: January 25, 2010)
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

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Michael Camilleri, MDMayo Clinic
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