CompletedPhase 3

Lubiprostone for Functional Constipation in the Under 18 Years Patients

Egypt274 participantsStarted 2022-01-01

Plain-language summary

The investigators will enroll subjects 8 - \< 18 years of age, fulfilling Rome IV criteria for functional constipation. Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets). safety and efficacy will be assessed.

Who can participate

Age range8 Years – 18 Years

SexALL

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Exclusion criteria

✕. If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors.
✕. If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation.
✕. Patients suffering from Hirschsprung's disease.
✕. Patients experiencing any alarming signs e.g. unexplained significant weight loss.
✕. Untreated fecal impaction at the time of enrollment.

What they're measuring

Primary outcome

Timeframe: At study week 16.

Trial details

NCT IDNCT05144295

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-25

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