30 Participants Needed

Tenapanor for Constipation

RA
SL
HP
Overseen ByHarichandana Punukula, PharmD, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Cedar Valley Digestive Health Center
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Tenapanor for treating constipation?

Research shows that Tenapanor is effective in treating constipation in patients with irritable bowel syndrome with constipation (IBS-C). In several studies, it was found to improve symptoms by targeting a specific process in the gut, offering a new option for those who do not respond well to traditional laxatives.12345

How is the drug Tenapanor unique for treating constipation?

Tenapanor is unique because it is a first-in-class drug that works by inhibiting the sodium/hydrogen exchanger in the gut, which is different from traditional laxatives that mainly focus on symptom relief. This mechanism allows it to be minimally absorbed in the body, potentially reducing side effects and offering a novel approach to treating constipation.12345

What is the purpose of this trial?

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Research Team

RA

Richard A. Manfready, MD, AM, FACP

Principal Investigator

Cedar Valley Digestive Health Center

RM

Ravindra Mallavarapu, MD

Principal Investigator

Cedar Valley Digestive Health Center

HP

Harichandana Punukula, PharmD, MS

Principal Investigator

Cedar Valley Digestive Health Center

Eligibility Criteria

This trial is for people aged 50-89 with Parkinson's disease (PD) stages 1-3, experiencing constipation. Participants must not be planning to conceive and should use contraception if applicable. They must have fewer than six bowel movements weekly, with less than three feeling complete, despite using laxatives.

Inclusion Criteria

I am between 50 and 89 years old, can prevent pregnancy, and have Parkinson's disease stages 1-3.
I have had 5 or fewer bowel movements a week and often feel I haven't completely emptied.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tenapanor 50 mg or placebo orally twice daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Tenapanor
Trial Overview The study tests Tenapanor against a placebo in treating constipation related to synucleinopathies like PD. It aims to see if Tenapanor can increase bowel movement frequency and improve stool consistency compared to no active treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TenapanorExperimental Treatment1 Intervention
Tenapanor 50 mg orally twice daily for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo orally twice daily for 12 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedar Valley Digestive Health Center

Lead Sponsor

Trials
1
Recruited
30+

Ardelyx

Industry Sponsor

Trials
31
Recruited
6,100+

Findings from Research

Tenapanor, a new treatment for irritable bowel syndrome with constipation (IBS-C), was found to be tolerable over a long-term period of up to 52 weeks, with a safety profile similar to that observed in shorter studies.
In a study involving 312 patients, the most common side effect was diarrhea, reported in 10.6% of participants, mostly mild or moderate, indicating that while side effects can occur, they are generally manageable.
Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study.Lembo, AJ., Friedenberg, KA., Fogel, RP., et al.[2023]
Tenapanor is a first-in-class oral medication for treating irritable bowel syndrome with constipation (IBS-C) that works locally in the gut by inhibiting the NHE3 transporter, which may lead to fewer systemic side effects and drug interactions.
Clinical trials (Phase 2b and 3) have demonstrated that tenapanor effectively meets both primary and secondary treatment goals, suggesting it could be a promising new option for patients with IBS-C who find conventional laxatives unsatisfactory.
Tenapanor for the treatment of irritable bowel syndrome with constipation.Sinagra, E., Rossi, F., Raimondo, D., et al.[2022]
In a phase 3 trial involving 629 patients with constipation-predominant irritable bowel syndrome (IBS-C), tenapanor 50 mg twice daily significantly improved symptoms, with 27% of patients achieving the primary endpoint compared to 18.7% in the placebo group.
While tenapanor was generally well tolerated, diarrhea was the most common side effect, leading to discontinuation in 6.5% of patients, indicating a need for monitoring in clinical use.
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).Chey, WD., Lembo, AJ., Rosenbaum, DP.[2022]

References

Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. [2023]
Tenapanor for the treatment of irritable bowel syndrome with constipation. [2022]
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). [2022]
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). [2023]
Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security