TEN-03-301
Study to assess the safety and efficacy of tenapanor for the treatment of chronic idiopathic constipation (CIC) in adults.
About This Study
This is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of tenapanor for the treatment of chronic idiopathic constipation (CIC) in adults when administered twice daily for 26 consecutive weeks.
Actively Recruiting
Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Chronic Idiopathic Constipation (CIC) in Adults
ClinicalTrials.gov ID:
Who May Participate
Individuals interested in participating in ACCEL must meet study inclusion and exclusion 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 constipation symptoms via an electronic diary (eDiary) device.
Inclusion criteria
- ≥18 to ≤80 years old at the screening visit
- Patient meets the Rome IV Diagnostic Criteria for functional constipation
– Lumpy/ hard stools more than 25% of defecations (criteria fulfilled for the last 3
months with symptom onset for at least 6 months prior to diagnosis)
– Loose stools are rarely present without the use of laxatives
– Insufficient criteria for irritable bowel syndrome - Females must be of non-childbearing potential or agree to the use of an acceptable
means of contraception - Males must agree to use an appropriate method of barrier contraception
- Patient meets the entry criteria assessed during the 2-week Screening period
- Ability to understand the assessments in the eDiary and how to use the eDiary device
- Patient must provide written informed consent before the initiation of any study-specific
procedures - Daily access to eDiary via a computer, tablet or smart phone
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 study medication or placebo. During the 26-week randomized treatment period (RTP), patients will continue recording daily assessments via the eDiary system. Patients will return for study visits every two or four weeks and will undergo standard safety assessments at these visits.
26 weeks
Length of study treatment
Up to 10
Number of study visits
4 weeks
Treatment 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 ACCEL?
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 32 weeks (a 2-week Screening period to determine if you are eligible for the study followed by a 26-week Treatment Period and a 4- week follow-up period).
What is a randomized, double-blind, placebo-controlled, dose-ranging 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 complete spontaneous bowel movements (CSBMs) from baseline for patients on tenapanor versus placebo. CSBMs are considered complete bowel movements unaided by laxatives.
Additionally, questionnaires will be administered at various time points in the study. These will help to measure severity of the constipation symptoms, impact of constipation on patient’s wellbeing and daily functioning, and overall satisfaction with the study medication’s ability to relieve symptoms of CIC.
Are there benefits to participating in ACCEL?
Your symptoms of chronic idiopathic constipation (CIC) 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 CIC patients in the future.
Are there risks to participating in ACCEL?
There are potential harms or risks if you take part in this study. Diarrhea is the most common side effect of IBSRELA, and it can sometimes be 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, whether you think they are related to the study drug or not.
Tenapanor contains a warning 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% vs 4%)
- Abdominal distension (swelling or bloating) (3% vs <1%)
- Flatulence (having gas) (3% vs 1%)
- Dizziness (2% vs <1%)
Please see Medication Guide within the full Prescribing Information for additional risk information.