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Trial · NCT06460038

Tenapanor in Synucleinopathy-Related Constipation

NCT06460038, Phase 2, Recruiting, Cedar Valley Digestive Health Center

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Tenapanor in Synucleinopathy-Related Constipation. Trials, record NCT06460038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06460038

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Tenapanor in Synucleinopathy-Related Constipation
NCT number
NCT06460038
Status
Recruiting
Phases
Phase 2
Enrollment
30 participants, estimated
Lead sponsor
Cedar Valley Digestive Health Center
Conditions
Synucleinopathy, Parkinson's Disease
Interventions
Tenapanor, Placebo
First posted
2024-06-14
Last updated
2025-02-10

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryComplete spontaneous bowel movements (CSBM)6 of 12 weeks
Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
SecondaryAbdominal pain and bloating response6 of 12 weeksDecrease in severity score of at least 20% or more from baseline in 6 of 12 weeks (pain visual analog scale 1-10 where 10 is worst pain)
SecondaryCalprotectinWeek 12Decrease in fecal calprotectin by 20% or greater
SecondaryLipopolysaccharide binding proteinWeek 12Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline
SecondaryComplete spontaneous bowel movements (CSBM) continuousWeek 12
CSBM treated as a continuous variable. The investigators expect an increase of CSBMs in the treatment group compared to the placebo group. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
SecondaryPlasma zonulinWeek 12Decrease in zonulin by 20% compared to baseline

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
28244495BACKGROUNDPubMed
31934897BACKGROUNDPubMed
33337659BACKGROUNDPubMed
34276285BACKGROUNDPubMed
35633466BACKGROUNDPubMed
36801916BACKGROUNDPubMed
37562457BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06460038

GET https://conductscience.org/api/trials/v1/NCT06460038/registered