Northern California Research is conducting a study for adolescents (ages 12-18) who have chronic constipation. The purpose of this study is to find out if an already FDA approved medication has beneficial effect in adolescents who have chronic constipation.
The study drug causes an increase in the amount of fluid in the intestines, making bowel movements easier. It works in a way that is similar to a natural protein produced normally and present in the body. A large research study of with adults showed that subjects taking the study medication had more bowel movements, better stool consistency, and less straining during bowel movements compared to subjects taking placebo (or “sugar pill”).
The treatment will be “blinded”, which means neither you, your child nor the study doctor will know whether the patient will be receiving the real study drug or the dummy study drug (placebo). However, this information will be available to the study doctor if needed in an emergency. Your child will be randomly assigned by chance (like the flip of a coin) to receive either 0.5 mg of study medication, 1.0 mg of study medication, 1.5 of study medication or placebo] (inactive substance). Your child will have a 75% (3 in 4) chance of receiving study medication and a 25% (1 in 4) chance of receiving placebo
Just in case the medicine that is being used does not have the desired effect, or not to the extent that we wish it to have, the patient will be given a “rescue medication” - Dulcolax®. Dulcolax® is a laxative which the patient will be able to take only when he/she has NOT had a bowel movement for 3 days.
The study length is 3-3.5 months and there will be 5 office visits.