Your child or teenager may be eligible to take part in the 2Go Study if they:
- Are between 6 months and 17 years old and weigh at least 12 lbs (5.5 kg)
- Have fewer than 3 bowel movements per week
- Have at least one or more of the following symptoms for a month or longer:
- Inability to control bowel movements (BMs) causing poop to leak unexpectedly
- Retentive Posturing (holding the body in such a way as to purposely prevent a BM)
- Painful or hard BMs
- Large stools that can clog a toilet or that are large in diameter
- A history of voluntarily withholding stool (purposely trying not to poop)
There are additional criteria that are reviewed by the study team at the study center at the first appointment.
If your child qualifies for the 2Go Study, it will involve taking the study medication, visiting the study center or attending study visits by phone, recording your child’s bowel movement and study medication dosing information in an eDiary (an electronic diary that captures data), and completing study procedures.
This initial appointment is an opportunity to:
- Learn more about the 2Go Study. Your child will be speaking with a study coordinator at the study center to learn more regarding their participation in this study.
- Ask any important questions. These can be any questions you or your child may have about this study or clinical research in general.
- Determine if the 2Go Study may be right for your child. After speaking with the study coordinator and learning details about this study, the research staff will perform a series of screening tests to determine if your child pre-qualifies to participate. If they pre-qualify, they will be given an opportunity to decide if participation is right for them. If they agree to take part, the center will ask them to review and sign an assent form.
If eligible, your child will be in the study for a little over 1 year, during which time participants will be required to attend approximately 24 study visits. During the first part of the study, there will be weekly visits and some of these visits will be conducted over the phone. During the second part of the study, there will be monthly visits, and some of these visits will be also conducted over the phone. The final study visit will be conducted over the phone.
This study is evaluating the safety and effectiveness of a study medication, called prucalopride, in treating children and teenagers with constipation. Prucalopride has already been approved in the United States for the treatment of constipation in adults.
If your child qualifies for the 2Go Study, there is a one in three chance they may receive a placebo during the first part of the study. You, your child, and the study team won’t know which study treatment group your child is in. In the second part of the study, all participants will receive the study medication. The study coordinator can answer any questions you or your child have about the 2Go Study.
Do not discontinue any medication unless your child is advised to do so by the study center staff or your child’s primary care physician.
Qualified participants will receive study-required medical care and study medication at no cost. The study will not pay for other medical care or current medication(s) needed to support your child’s daily health care routine. You may receive reimbursement for study-related expenses. If your child pre-qualifies, they can speak with the study center for more information.
No, health insurance is not required in order to participate.
Research studies are designed in specific ways to test the study medication for safety and effectiveness. One or more of the answers that you provided about their health status were outside of the eligibility criteria for this study. This does not mean your child will not qualify for different research studies.
About Research Studies
A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety of potential new medications and to find out how well they work. These studies must be performed before a potential new medication or treatment can be approved for use in patients and sold to the general public.
It is important to test medications and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Participants will be selected based on the eligibility criteria and the number of participants needed by the researchers.
Research studies are used to test medications before they are available to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential medication. By participating in a study, you may help bring new and improved treatments to patients in need.
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is qualified to participate, locations, and phone numbers to call for more information.
For those who are qualified, taking part in research studies offers several benefits:
- Getting actively involved in their own health care
- Having access to potentially new research treatments
- Having access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied
- Helping others by contributing to medical research
It is important to test medications and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
