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Tests treatment safety and results for Chronic Idiopathic Constipation (CIC)
Official title A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
ClinicalTrials.gov ID: NCT07382167
What this study is testing
What is Tenapanor 5 mg BID?
Tenapanor 5 mg BID is an investigational medicine, given as an once-weekly, being studied as a potential treatment for chronic idiopathic constipation (cic).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients ≥18 to ≤80 years old at the Screening visit (Visit 1).
- Meet the Rome IV Diagnostic Criteria for functional constipation.
- Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study...
- Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization.
- Meets the entry criteria assessed during the Screening period.
You likely can't join if
- Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3...
- Fecal impaction within 6 months prior to the Screening visit
- Unexplained and clinically significant alarm symptoms.
- Functional diarrhea as defined by Rome IV criteria
- IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria
- Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit
See the full eligibility criteria
- Patients ≥18 to ≤80 years old at the Screening visit (Visit 1).
- Meet the Rome IV Diagnostic Criteria for functional constipation.
- Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication.
- Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization.
- Meets the entry criteria assessed during the Screening period.
- Ability to understand and provide input on the assessments in the eDiary.
- Provide written informed consent before the initiation of any study-specific procedures.
- Must agree to have daily access to eDiary via a computer, tablet or smart phone
- Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3 months prior to the Screening visit
- Fecal impaction within 6 months prior to the Screening visit
- Unexplained and clinically significant alarm symptoms.
- Functional diarrhea as defined by Rome IV criteria
- IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria
- Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit
- Patient with central nervous system disorder
- Use of prohibited medications defined by protocol
- Patient has a history or current evidence of laxative abuse
- Hepatic dysfunction
- Positive HIV, hepatitis B or hepatitis C test at screening
- Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD)
- Any evidence of or treatment of malignancy within 1 year prior to the Screening visit
- Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit
- Pregnant women or women planning to become pregnant during trial participation
- A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit.
- Alcohol or substance abuse within 1 year prior to the Screening visit
- Participation in other clinical trials within 1 month prior to the Screening visit
- Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial
The study team makes the final eligibility decision.
Where it's taking place
- Foley, Alabama, United States
- Saraland, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Sun City West, Arizona, United States
- Tucson, Arizona, United States
- North Little Rock, Arkansas, United States
- Canoga Park, California, United States
- Chula Vista, California, United States
- Inglewood, California, United States
- Lancaster, California, United States
- Lincoln, California, United States
- San Diego, California, United States
- San Jose, California, United States
- Santa Ana, California, United States
- Denver, Colorado, United States
- Lakewood, Colorado, United States
- Longmont, Colorado, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
+ 81 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Foley, Alabama, United States; Saraland, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Sun City West, Arizona, United States; Tucson, Arizona, United States and 95 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.