Tenapanor for Constipation

Overseen By Harichandana Punukula, PharmD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedar Valley Digestive Health Center

Disqualifiers: Diarrhea, GI abnormalities, Hepatic dysfunction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Richard A. Manfready, MD, AM, FACP

Principal Investigator

Cedar Valley Digestive Health Center

Ravindra Mallavarapu, MD

Principal Investigator

Cedar Valley Digestive Health Center

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

Group I: Tenapanor Experimental Treatment 1 Intervention

Tenapanor 50 mg orally twice daily for 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo orally twice daily for 12 weeks

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a phase 3 trial involving 620 patients with irritable bowel syndrome with constipation (IBS-C), tenapanor 50 mg twice daily significantly improved abdominal pain and bowel movement frequency compared to placebo, with 36.5% of patients responding positively versus 23.7% in the placebo group.

Tenapanor was generally well tolerated, with diarrhea being the most common side effect, but it was usually mild to moderate and led to discontinuation in only 6.5% of patients on tenapanor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Chey, WD., Lembo, AJ., Yang, Y., et al.[2023]

In a phase 2 study involving 356 patients with constipation-predominant irritable bowel syndrome (IBS-C), tenapanor 50 mg taken twice daily significantly improved bowel movement frequency, with a complete spontaneous bowel movement (CSBM) responder rate of 60.7% compared to 33.7% in the placebo group.

Tenapanor also effectively reduced abdominal symptoms, with a composite responder rate of 50.0% in the 50 mg group versus 23.6% in the placebo group, although diarrhea was noted as a common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. Chey, WD., Lembo, AJ., Rosenbaum, DP.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Tenapanor for the treatment of irritable bowel syndrome with constipation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. [2018]