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Irritable Bowel Syndrome With Constipation (IBS-C)Phase 2NCT06553547

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

A Phase 2 study testing Tenapanor in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Ardelyx at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old. Read more about this study

Who is it for?
Ages 6 to 11 years
What is being tested?
Tenapanor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
20 sitesUnited States
Study dates
24 Jul 2024to 7 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • ≥6 and <12 years old at the Screening visit (Visit 1)
  • Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential.
  • Meet the Modified Diagnostic 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)
  • Meet 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 verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures

Who cannot join

  • Functional diarrhea as defined by Modified Rome IV child/adolescent criteria
  • IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria
  • History of non-retentive fecal incontinence;
  • Required manual disimpaction any time prior to randomization (after consent)
  • Currently 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:
Show all 33Show fewer
  • Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
  • Cystic fibrosis;
  • Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
  • Down's syndrome or any other chromosomal disorder;
  • Active anal fissure (Note: History of anal fissure is not an exclusion);
  • Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
  • Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
  • Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
  • Lead toxicity, hypercalcemia;
  • Neurodevelopmental disabilities
  • 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 and could confound the assessments in this study
  • History of cancer other than treated basal cell carcinoma of the skin;
  • 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:
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • Boys Town National Research Hospital

    Boys Town, Nebraska, 68010

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Maspons Pediatric Gastro

    El Paso, Texas, 79902

  • Proactive El Paso, LLC

    El Paso, Texas, 79902

  • Prisma Health Children's Hospital

    Greenville, South Carolina, 29615

  • Texas Digestive Specialists

    Harlingen, Texas, 78550

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • University Physicians and Surgeons, Inc

    Huntington, West Virginia, 25701

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

  • Mankato Clinic Children's Health Center

    Mankato, Minnesota, 56001

  • Waterway Research & Associates Corp.

    Miami, Florida, 33155

  • Valencia Medical and Research Center

    Miami, Florida, 33165

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

    Orlando, Florida, 32806

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Florida Pharmaceutical Research and Associates, Inc.

    South Miami, Florida, 33143

  • Pioneer Research Solutions Inc

    Sugar Land, Texas, 77479

  • Wilmington Health

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Read the detailed description

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment.

During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period.

The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

Being tested
Tenapanor, Placebo
Keywords
IBS-C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TenapanorDrug

    Also called IBSRELA

    Tenapanor 5 mg/mL solution

  • PlaceboDrug

    Matching Placebo solution

Study groups in NCT06553547
Study groupRoleWhat they receive
Tenapanor Cohort 1ExperimentalTenapanor 2 mg BID
Receives: Drug: Tenapanor
Tenapanor Cohort 2ExperimentalTenapanor 5 mg BID
Receives: Drug: Tenapanor
Tenapanor Cohort 3ExperimentalTenapanor 10 mg BID
Receives: Drug: Tenapanor
Tenapanor Cohort 4ExperimentalTenapanor 15 mg BID
Receives: Drug: Tenapanor
Tenapanor Cohort 5ExperimentalTenapanor 20 mg BID
Receives: Drug: Tenapanor
Tenapanor Cohort 6ExperimentalTenapanor 25 mg BID
Receives: Drug: Tenapanor
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average weekly SBM (week 4)

    Change from baseline in average weekly SBM frequency in Week 4

    Measured: 4 weeks

Secondary outcomes (5)

  1. Average weekly SBM (weeks 1, 2 and 3)

    Change from baseline in average weekly SBM frequency in Week 1, Week 2, and Week 3

    Measured: 3 weeks

  2. SBM Response

    Weekly ≥3 SBM response: achieving an average weekly SBM frequency ≥3 for a given week

    Measured: 6 weeks

  3. Stool consistency

    Percent change from baseline in average weekly stool consistency score in each week

    Scale Range:

    1. one (1)= Rabbit droppings: separate hard lumps, like nuts (hard to pass)
    2. seven (7) for Gravy: watery, no solids pieces, entirely liquid"

    Measured: 6 weeks

  4. Abdominal Pain Score

    Percent change from baseline in average weekly abdominal pain score in each week

    Scale Range:

    zero (0) = no pain and ten (10)= very severe abdominal pain

    Measured: 6 weeks

  5. Rescue medication

    Overall use of rescue medication

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start24 Jul 2024
  3. Primary completion7 Jul 2026
  4. Study completion7 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553547
Sponsor's protocol ID
TEN-01-202
Status last verified
Aug 2026
First submitted
12 Aug 2024
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tenapanor in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Ardelyx at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average weekly SBM (week 4) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06553547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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