Clinical trial: Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children (NCT00403819)

Eligibility criteria:
Inclusion Criteria:

        Male and female patients of any ethnic origin will be eligible to participate in the study
        if all of the following criteria are fulfilled.

          -  informed consent having been obtained from the patient's parent or guardian and assent
             from the child if they are capable of understanding the study

          -  aged 24 months - 11 years

          -  experiencing constipation as defined as:

               -  ≤2 complete bowel movements per week, and at least one of the following:

                    -  pain on defaecation on ≥1 in 4 days

                    -  1/4 or more of bowel movements with straining

                    -  1/4 or more of bowel movements with hard or lumpy stools

          -  patients in whom these symptoms have been present for ≥3 months

          -  available to complete the study and able to comply with requirements and restrictions
             listed in the patient's/parent's information documents.

        Exclusion Criteria:

        Patients will not be eligible to participate in the study if any of the following
        conditions apply:

          -  faecal impaction or history of faecal impaction

          -  history of intestinal perforation or constipation

          -  paralytic ileus

          -  toxic megacolon

          -  Hirschsprungs disease

          -  severe inflammatory conditions of the intestinal tract

          -  severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis,
             respiratory aspiration, failure to thrive or other recognised complications of
             gastro-oesophageal reflux

          -  patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium
             picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per
             day for children > 6 years (i.e. high doses of stimulant laxatives)

          -  any other significant medical condition that in the investigator's opinion would
             effect their suitability for entry into the study

          -  patients who have previously received Movicol or previously participated in the study

          -  known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of
             Movicol

          -  patients with diabetes as the placebo to be used in this study is sucrose

          -  patients who have received any investigational drug in the last 3 months

          -  patients and/or parents who the investigator thinks could not comply with the
             requirements of the protocol for any reason (particularly in relation to reliable
             completion of diary cards)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Months old.
Subject must be at most 11 Years

Patient description (medical language): A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days.  The patient has had constipation and discomfort with bowel movements since birth.  His symptoms worsened after eating semi-solid foods.  Vital signs are normal.  Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds.  Xray with barium shows a narrow rectum and rectosigmoid area.  The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine.

Patient description (patient's own words): My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine.

Does the patient match the trial criteria? Contradiction