Asthma

  • STATUS
    None
  • sponsor
    Chiesi
Updated on 23 November 2020

Summary

Asthma

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.

The study consists of 3 periods:

run-in period: Screening visit (SV) to randomization visit (RV), 14-21 days (2-3 weeks) prior to study start

double-blind treatment period: RV through the final treatment visit, 85±3 days or 12 weeks after study start.

follow-up period: a follow-up visit/telephone call, 7±3 days after the treatment period ends.

  • Study-related care from a Doctor
  • Pulmonary Functional Test
  • Free asthma medication
  • Compensation up to $75 for each visit completed (7 visits in 4 months)

Details
Clinical Study IdentifierTX239
SponsorChiesi
Last Modified on23 November 2020

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