CompletedPhase 4

Colonic Motor Patterns in Healthy Volunteers

Belgium15 participantsStarted 2018-06-27

Plain-language summary

Characterization of motor patterns with opioid agonists (codeine) ingestion, and their reversal by a peripherally acting mu-opioid receptor antagonist (Naloxegol).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. HV is a man or woman aged 18 to 65 years, inclusive, at prescreening.
✓. Normal stool pattern of between 3 defecations per day and 3 per week with a Bristol Stool Form Scale (BSFS) of 1, 2, 6 or 7 in less than 25% of defaecations.
✓. HV has not used any opioid medication 14 days prior to randomization.
✓. Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). HV must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at prescreening. HV on stable doses of antidepressants (i.e., for the 3 months prior to prescreening) will be allowed to participate in the study. As needed use of benzodiazepines, if habitual, is permitted.
✓. Female subjects must either be:
✓. postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at prescreening,
✓. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
✓. abstinent, or

Exclusion criteria

✕. HV has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis), celiac disease and functional bowel disorder.
✕. HV has a history of diverticulitis.
✕. HV has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
✕. HV has any of the following surgical history:
✕. Any abdominal surgery within the 3 months prior to prescreening;
✕. HV has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
✕. HV has current evidence of laxative abuse.
✕. HV has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening.

What they're measuring

Overall prevalence of anterograde colonic motor patterns in the different treatment categories.

Timeframe: 3 times for 6 hours

Trial details

NCT IDNCT05770960

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-09

View on ClinicalTrials.gov More Opioid-Induced Constipation trials