Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2025-12-31

Brief Summary

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This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and \<18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.

Detailed Description

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This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP) and a 2-week treatment-free Follow-Up period (only for patients who will not enter the 40-week Long Term Safety Extension Study \[TEN-01-306\]). 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.

Patients who do not enter the 40-week Long Term Safety Extension Study \[TEN-01-306\] including those who complete the RTP but do not enter study TEN-01-306 and those who prematurely discontinue from the RTP, a Follow-Up Visit will be scheduled approximately 2 weeks after the completion of the RTP (Visit 6) or the Early Termination Visit at which safety assessments will be performed

Conditions

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Irritable Bowel Syndrome With Constipation (IBS-C)

Keywords

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IBS-C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tenpanor 50 mg BID

Patients will be randomized to receive 50 mg tenapanor twice daily

Group Type EXPERIMENTAL

Tenapanor 50 MG

Intervention Type DRUG

Participants will receive tenapanor 50 mg BID (total of 100 mg daily)

Tenpanor 25 mg BID

Patients will be randomized to receive 25 mg tenapanor twice daily

Group Type EXPERIMENTAL

Tenapanor 25 mg bid

Intervention Type DRUG

Participants will receive tenapanor 25 mg BID (total of 50 mg daily)

Placebo Comparator

Patients will be randomized to receive matching placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be randomized to receive matching placebo

Interventions

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Tenapanor 50 MG

Participants will receive tenapanor 50 mg BID (total of 100 mg daily)

Intervention Type DRUG

Tenapanor 25 mg bid

Participants will receive tenapanor 25 mg BID (total of 50 mg daily)

Intervention Type DRUG

Placebo

Participants will be randomized to receive matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥12 and \<18 years old
* Patient weighs ≥18 kg at the time the patient provides written assent
* Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
* Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C
* Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
* Patient meets the entry criteria assessed during the 2-week Screening period.
* Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
* Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures

Exclusion Criteria

* Functional diarrhea as defined by Rome IV child/adolescent criteria
* IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria
* History of non-retentive fecal incontinence.
* Required manual disimpaction any time prior to randomization (after consent);
* Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal \[GI\] bleeding \[rectal bleeding or heme-positive stool\], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
* Patient has any of the following conditions:

* Celiac disease, or positive serological test for celiac disease
* Cystic fibrosis
* Hypothyroidism that is untreated or treated with thyroid hormone
* Down's syndrome or any other chromosomal disorder
* Active anal fissure
* Anatomic malformations (eg, imperforate anus)
* Intestinal nerve or muscle disorders (eg, Hirschprung disease)
* Neuropathic conditions (eg, spinal cord abnormalities)
* Lead toxicity, hypercalcemia
* Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device)
* Inflammatory bowel disease
* Childhood functional abdominal pain syndrome
* Childhood functional abdominal pain;
* Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
* Lactose intolerance that is associated with abdominal pain or discomfort
* History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.)
* History of diabetic neuropathy.
* Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator.
* Patient has had surgery that meets any of the following criteria:

* Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit;
* Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
* An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
* Other major surgery during the 30 days before the Screening Visit
* History of alcohol or substance abuse
* Participation in other clinical trials within 1 month prior to Screening
* Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial
* If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Rosenbaum, PhD

Role: STUDY_CHAIR

Ardelyx

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United States

Central Contacts

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Jocelyn Tabora

Role: CONTACT

Phone: 510-745-1724

Role: primary

Nicole Finley

Role: primary

Markitta Miller

Role: primary

Other Identifiers

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TEN-01-304

Identifier Type: -

Identifier Source: org_study_id

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Tenpanor 50 mg BID

Tenapanor 50 MG

Tenpanor 25 mg BID

Tenapanor 25 mg bid

Placebo Comparator

Placebo

Interventions

Tenapanor 50 MG

Tenapanor 25 mg bid

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ardelyx

Responsible Party

Principal Investigators

David Rosenbaum, PhD

Locations

G & L Research, LLC

Eclipse Clinical Research

Advanced Research Center, Inc.

Prohealth Research Center

I.H.S. Health, LLC

Valencia Medical and Research Center

Orlando Health, Inc.- APH Center for Digestive Health and Nutrition

Florida Pharmaceutical Research and Associates, Inc.

Clinical Research Institute

OSF Saint Francis Medical Center

Boston Children's Hospital

Children's Mercy Hospital

Boys Town National Research Hospital

Med Clinical Research Partners, LLC

University of New Mexico Health Sciences Center

SUNY Downstate Medical Center

Advantage Clinical Trials

Atrium Health

M3 Wake Research, Inc

Frontier Clinical Research, LLC

Frontier Clinical Research, LLC

Velocity Clinical Research, Providence

Prisma Health Children's Hospital

Advance Clinical Trial PLLC

Maspons Pediatric Gastro

Proactive Clinical Research

Texas Digestive Specialists

AIM Trials, LLC

Sun Research Institute

Pioneer Research Solutions Inc

ClinPoint Trials

University Physicians and Surgeons, Inc.

Frontier Clinical Research

Countries

Central Contacts

Jocelyn Tabora

Susan Edelstein, PhD

Facility Contacts

Christine Fuller

Felice Anderson

Grecia Amezcua

Lilia Contreras

Johanna Garcia

Daniela Baeza

Kelvisha Norton

Cinzia Karpf

Beverley Jenkins

Drewann Whalen

Christopher Chalmers

Corey Shurman

Samantha Sack

Arodis Mateo, MD