Pediatric Constipation

Ages 6 – 17 Years Old

Moderate to Severe Constipation

We are looking for children and adolescents 6 to 17 years of age who suffer from constipation to take part in a research study for an investigational drug for constipation.

Participants must:

  • Be 6-17 years of age
  • Have constipation
  • Be willing to complete a daily diary

About Pediatric Constipation

Functional constipation is a common health issue for children of all ages. It can cause infrequent and hard stools, usually accompanied by discomfort and abdominal pain.

Constipation can have a severe impact on a child’s quality of life and can lead to missed school, withdrawal from social activities, and have a substantial financial burden on families or individuals who need to have medical intervention. The SPARK-64 Study is looking to evaluate the effectiveness and safety of an investigational drug for treating constipation in 6 to 17-year old children.

What is a Clinical Research Study?

A Clinical Research Study is a study that helps to answer important questions about an investigational drug or device, such as: “Does it work and is it safe to use?” Every day, new information about medical conditions and possible therapies to treat those conditions are discovered through Clinical Research Studies.

What Will the Study Involve?

Participation in the SPARK-64 Study will last about 20 weeks and will include approximately 8 visits to the study clinic.

As the first step, you will be given details about the study, and if you consent to participate in the study, will complete preliminary tests. If you qualify, you may receive the new investigational drug and undergo various assessments at follow-up visits.

All study-related care is provided to you at no cost. You do not need health insurance to participate.

The SPARK-64 Study

The SPARK-64 Study is looking to evaluate the effectiveness and safety of an investigational drug to see how well it works for treating constipation in 6 to 17-year old children.
The SPARK-64 Study will include approximately 326 children between the ages of 6 and 17 years old who suffer from constipation and will take place at approximately 140 research centers across the United States of America, Canada, and Europe.

If you/the child in your care has been suffering from constipation, they may be eligible to take part in the SPARK-64 Study.

You/your child may be eligible to take part in the SPARK-64 Study if you:

  • Have 2 or fewer bowel movements per week, without laxatives
  • Are between 6 and 17 years old
  • Weigh more than 39lbs/18kg

Please speak with a member of our staff to see if the SPARK-64 Study is right for you or your child.

Is There a Cost to Participate?

Participants will receive all study-related care from a team of medical professionals at no cost.

If you decide to take part:

  • You will receive study-related care throughout the study from a team of experienced doctors and nurses.
  • The investigational drug, study-related healthcare and supplies will be provided at no cost to you or your insurance company.
  • Parents/Participants who take part in the study may receive compensation for their time and travel.

Contact Us to Participate

If you qualify to participate in a clinical trial based upon one of your medical conditions, then the medical care and medication for that medical condition will be provided at no cost to you and you will receive financial compensation for your time & travel.

Tell us a little bit about yourself and we’ll contact you for further information to determine eligibility for current and future studies.

Please note that any information you provide below is stored securely and will not be shared with anyone outside of Oviedo Medical Research. We will use this information only to help us determine if you qualify for participation in one of our studies.


















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