R-ALLY Study

TEN-01-304

Study to assess safety and efficacy of tenapanor for treatment of irritable bowel syndrome with constipation (IBS-C) in pediatric patients 12 to less than 18 years.

About This Study

This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor in pediatric patients, ages 12 to under 18, with IBS-C when administered twice daily for 12 consecutive weeks.

Actively Enrolling

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

ClinicalTrials.gov ID: NCT05643534

ClinicalTrials.gov

Who May Participate

Individuals interested in participating in R-ALLY must meet certain criteria to qualify for screening and enrollment into the study.  After signing the informed consent, the patients 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 is critical.  If the patient makes fewer than 10 entries out of the first 14 days, the patient will not be eligible to participate.  The patient ediary entries will be monitored actively by the site staff and will be reviewed to determine eligibility at the end of screening.

Inclusion criteria

  • ≥12 and <18 years old
  • Females of child-bearing potential must have negative pregnancy test 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
  • Patient meets the entry criteria assessed during the two-week screening period
  • Ability of both the patient and guardian 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 guardian must provide written informed consent before the initiation of any study-specific procedures

Joining a clinical trial is an important and personal decision. We thank you for considering participation as an option that may be right for you.

Study Procedures

Eligible patients will be randomized to receive one of the study medications: tenapanor 25 mg (5×5 mg tablets) bid, tenapanor 50 mg (1x50mg tablet) bid, or placebo.

During the 12-week double-blind randomized treatment period (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 visits every two or four weeks and will undergo safety assessments at these visits.

12 weeks

Length of study treatment

Up to 7

Number of study visits

Up to 40 weeks

Long-term follow-up

Find a Trial Location

Search by state to find a trial location near you. Trial locations may change over time.

Frequently Asked Questions

Will my travel expense be reimbursed for participation in R-ALLY?

For your time and inconvenience related to your participation in this study, you may be compensated for each study visit you complete.

What is the time commitment for participation?

Your participation in this research will last approximately 14-16 weeks (a 2-week Screening period to determine if you are eligible for the study followed by a 12-week Treatment period and, if you do not continue into the Long Term Extension Study (TEN-01-306), a 2-week treatment free period and a Follow-up Visit).

What is a randomized, double-blind, placebo-controlled study?

A randomized, double-blind, placebo-controlled study is a rigorous research design commonly used in clinical trials to evaluate the effectiveness of new treatments or interventions. Here’s a breakdown of what each term means:

Randomized: Participants are randomly assigned to different groups—usually an experimental group that receives the treatment and a control group that receives a placebo or standard treatment. This helps ensure that the groups are comparable and reduces bias.

Double-blind: Both the participants and the researchers involved in administering the treatment and assessing the outcomes do not know which group participants are in (i.e., which group is receiving the treatment and which is receiving the placebo). This helps prevent bias in treatment administration and outcome assessment.

Placebo-controlled: The study includes a control group that receives a placebo, which is an inactive substance designed to look like the treatment but has no therapeutic effect. This helps determine whether the treatment has a genuine effect or if improvements are due to participants’ expectations or other factors.

Overall, this study design helps ensure the validity and reliability of the results by minimizing biases and controlling for various factors that could influence the outcome.

What is the study measuring?

The study is measuring spontaneous bowel movement frequency, consistency and abdominal pain from baseline for patients on tenapanor versus placebo.

Are there benefits to participating in R-ALLY?

Your symptoms of irritable bowel syndrome (IBS) may or may not improve and could even worsen if you take part in this study. There is no expected direct medical benefit to you from participating in this study. Your participation in the study will contribute to information about the study drug and may benefit IBS-C patients in the future.

Are there risks to participating in R-ALLY?

There are potential harms or risks if you take part in this study. The drugs you would take can cause side effects, sometimes severe. A side effect is an unintended result of the treatment that is not related to the reason the treatment is being used. Some are common and some are rare. Please tell the study doctor or study staff right away if you have any side effects or any other problems with your health whether or not you think these problems are related to the study drug.

Tenapanor contains a warning for risk of serious dehydration in pediatric patients. In the most recent 26-week placebo-controlled study in about 600 people with IBS-C, the most common side effects associated with taking tenapanor that were reported in more than 2% of tenapanor-treated people and were greater than placebo include:

  • Diarrhea (16%)
  • Abdominal distension (swelling or bloating) (3%)
  • Flatulence (having gas) (3%)
  • Dizziness (2%)

Please see Medication Guide within the full Prescribing Information for additional risk information.