Adolescent Constipation

  • STATUS
    Recruiting
  • sponsor
    Synergy Pharmaceuticals
Updated on 25 March 2021

Summary

Adolescent Constipation

Description

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 the study medication has beneficial effect in adolescents who have CIC. This study medication is approved by the FDA for use in adults; the use of this drug in children is investigational. The study drug medication 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 with this study medication in adults showed that subjects taking it 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 medication or the dummy study medication (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, 1.0 mg, 1.5 mg of the study medication or placebo (inactive substance). Your child will have a 75% (3 in 4) chance of receiving the study medication and a 25% (1 in 4) chance of receiving placebo.

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. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

Details
Condition Constipation
Clinical Study IdentifierTX152643
SponsorSynergy Pharmaceuticals
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and Females 12-18 years old
Having 2 or fewer bowel movements per week

Exclusion Criteria

Having a history of an eating disorder
Unable to tolerate rescue medication (Dulcolax®), or unwilling to use it as the only laxative for the duration of the trial
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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