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Mental Health

General Medicine

Psychedelic

Currently Enrolling

Pediatric Irritable Bowel Syndrome With Constipation (IBS-C)

This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP). At the beginning of the 2-week Screening period, patients who provide written assent will be fully assessed for eligibility into the study and will be asked to self-report daily information about the status of their IBS symptoms via an electronic diary (eDiary) device. Patient compliance with the eDiary will be monitored actively by the site staff and will be reviewed to determine eligibility at the end of screening. Eligible patients will be randomized to receive one of the study medications: tenapanor 25 mg BID, tenapanor 50 mg BID, or placebo. During the 12-week double-blind RTP, patients will continue recording daily assessments via the eDiary system as instructed and compliance with eDiary entries will be monitored on an ongoing basis. Patients will return for study visit every two or four weeks (Visits 3-6) and will undergo safety assessments at these visits.

Study Location: 

Plano, TX

Dates

11/15/22-10/31/24

In-Patient

Multicenter, Open-Label

Drug

Tenapanor 50 MG; Tenapanor 25 MG bid; Placebo

Compensation

Compensation for time and travel

Participant Requirements

Age

12-18 Years

Gender

All

Time Commitment

102 weeks

Health Status

Child/Adolescent IBS

what to expect

We lay it all out so there are no surprises

Let us know which trial interests you

The first step is reaching out to us. Read through our website, find a trial that might be right for you, then complete the short form and we’ll follow up right away. You can also always just give us a call.

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Meet with one of our licensed clinicians

We will first conduct a phone screening with you. If it looks like you or your loved one might qualify for a research study, we’ll set an in-person consultation to move forward with the study and determine qualifications.

Participate in your clinical trial

Aim Trials conducts a variety of studies. Some are out-patient, meaning you come in for appointments and likely take a medication from home. Others are in-patient, meaning you’ll spend some time at our facility. Either way, our clinicians will help you through the various stages of your study.

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Get compensated for time and travel

At the end of your study, you’ll receive compensation for your time and travel. Compensation varies based on your study, so just ask your clinician before the trial begins.

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Our Expertise

Why Choose Aim?

Our Experience

Aim Trials is an experienced group of doctors and medical providers conducting mental and physical health research studies in pediatric and adult populations since 2004. Although we conduct a broad range of studies, we are considered a leader in mental health trials in DFW.

Patient-Centric
Philosophy

Everything we do is based on the welfare of our patients. We empathize with our patients and their families by proactively learning about their desires and needs. Our compassionate staff provides personalized treatment wherever possible throughout the entire study process.

Our People

Our patient-centric focus emanates from our team at Aim. Our founder has worked tirelessly to shatter the mental health stigma within our communities. This passion is embodied by our staff to provide an empathetic and caring approach within our medical research practice.

Get Started with Aim Trials

We are confident you will be impressed by our capabilities and services. Please contact us to inquire further about working together on an upcoming study.