Clinical trial: Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation (NCT00452335)

Eligibility criteria:
Inclusion Criteria:

          -  Less than 18 years of age

          -  Weight of at least 12 kg and capable of swallowing a capsule

          -  Able to refrain from use of medications known to treat or associated with constipation
             symptoms

          -  Stable fiber therapy or ADHD therapy if using such medications

          -  Patient/Caregiver able to complete daily diary

          -  Patient able to use recommended rectal and/or oral rescue medications if needed

        Exclusion Criteria:

          -  Constipation is associated with some medical, anatomic, physical, organic, or other
             condition

          -  Hirschsprung's Disease or Nonretentive Fecal Incontinence

          -  Untreated fecal impactions or impactions requiring digital manipulation

          -  Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator
             discretion

          -  Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or
             unexplained weight loss

          -  Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric
             disorder, other systemic disease, or abnormal laboratory tests at the investigator
             discretion

          -  If female, is currently pregnant or nursing, or plans to become pregnant or nurse
             during the clinical study

          -  Sexually active males and females must utilize acceptable birth control methods

          -  Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 17 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