Health TrialsbyHealthPanel

Tenapanor in Synucleinopathy-Related Constipation

ConditionsSynucleinopathyParkinson's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-89
SponsorCedar Valley Digestive Health Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50-89 years.

Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.

Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.

Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.

Disqualifiers

Functional diarrhea or IBS-D/M based on Rome IV Criteria.

Symptomatic structural GI abnormalities or inflammatory bowel disease.

Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine >2mg/dl) dysfunction.

Pregnancy or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tenapanor

    Drug

    Inhibitor of NHE3

  • Placebo

    Drug

    Placebo drug

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: TenapanorExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete spontaneous bowel movements (CSBM)

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

Time frame
6 of 12 weeks

Secondary outcomes

1

Abdominal pain and bloating response

Decrease 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)

Time frame
6 of 12 weeks
2

Calprotectin

Decrease in fecal calprotectin by 20% or greater

Time frame
Week 12
3

Lipopolysaccharide binding protein

Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline

Time frame
Week 12
4

Complete spontaneous bowel movements (CSBM) continuous

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

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedar Valley Digestive Health Center

Lead sponsor

Ardelyx

Collaborator

Source ClinicalTrials.gov
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