Imperial, CANCT07723924Now EnrollingIRB Ready

Functional Constipation (FC) Clinical Trial in Imperial, CA

Access cutting-edge functional constipation (fc) treatment through this phase 2 clinical trial at a research site in Imperial. Study-provided care at no cost to qualified participants.

Sponsored by Bausch Health Americas, Inc.

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Expert Care in Imperial

Access functional constipation (fc) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related functional constipation (fc) treatment provided free

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Check if you qualify for this functional constipation (fc) clinical trial in Imperial, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Imperial

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Imperial site if eligible
  4. 4Begin participation

About This Functional Constipation (FC) Study in Imperial

The goal of this clinical trial is to learn if plecanatide can treat functional constipation in children and adolescents aged 6 to less than 18 years. It will also learn about the safety and pharmacokinetics of plecanatide in this population. The main questions it aims to answer are: * Does plecanatide increase the number of spontaneous bowel movements compared to placebo after 8 weeks of treatment? * What medical problems do participants experience when taking plecanatide? Researchers will compare low-dose plecanatide and high-dose plecanatide to placebo to see if plecanatide improves bowel movement frequency, stool consistency, and constipation-related symptoms. Participants will: * Complete a screening period with daily electronic diary entries to record bowel movements, symptoms, and rescue medication use * Take plecanatide or placebo by mouth once daily for 8 weeks * Continue daily electronic diary entries throughout the study * Attend clinic visits for physical exams, laboratory tests, and assessments of symptoms and safety * Provide blood samples for pharmacokinetic and safety evaluations * Complete questionnaires about constipation symptoms and quality of life

Sponsor: Bausch Health Americas, Inc.

Who Can Participate

Inclusion Criteria

• Male or female children and adolescents aged 6 to \<18 years at time of consent.
Diagnosis of functional constipation (FC) based on Rome IV criteria for children/adolescents.
Participant and/or legally authorized representative able to provide informed consent/assent.
Participant/caregiver willing and able to comply with study procedures, including electronic diary (eDiary).
Completion of ≥5 out of 7 daily diary entries during each of the 2 baseline weeks.
Stable diet for at least 14 days prior to screening.
Females of childbearing potential must use highly effective contraception and have negative pregnancy tests.

Exclusion Criteria

Weight \<15 kg at screening/randomization.
History of anorectal malformations, neurological deficits, or anatomical abnormalities affecting bowel function.
Use of prohibited medications within 15 days prior to randomization (e.g., anticholinergics, 5-HT agents, opioids, other laxatives).
Use of any laxatives other than study-provided Dulcolax®.
Pregnant or breastfeeding participants.
Active eating disorder within the past 6 months.
Clinically significant medical conditions (hepatic, renal, gastrointestinal, endocrine, infectious) that may interfere with study.
Known hypersensitivity to plecanatide.
History of drug or alcohol abuse within 12 months.
Participation in another clinical trial within 30 days.
Non-compliance with eDiary requirements (\<5/7 entries per week).
Use of rescue medication more than 2 days per week during baseline.
≥3 spontaneous bowel movements (SBMs) per week during baseline.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Imperial?

Yes, this clinical trial (NCT07723924) has an active research site in Imperial, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Functional Constipation (FC) Treatment Options in Imperial, CA

If you're searching for functional constipation (fc) treatment options in Imperial, CA, this clinical trial (NCT07723924) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Imperial research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced functional constipation (fc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all functional constipation (fc) clinical trials near you to find additional studies recruiting in your area.

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