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New treatment option for Cystic Fibrosis
Official title Assessing Tenapanor as a Treatment of CF-related Constipation.
ClinicalTrials.gov ID: NCT06810167
What this study is testing
What is Tenapanor?
Tenapanor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cystic fibrosis.
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
- Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients.
- Phase 3: a large, late-stage study
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 75
You may be able to join if
- Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
- Meeting criteria for CFrC Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months...
- Straining in at least 25% of defecations
- Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)
- Sensation of incomplete evacuation more than 25% of defecations
You likely can't join if
- Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is...
- Inability to discontinue standing bowel regimen (including fiber, stool softener, as well as either osmotic or stimulant laxative, pro-kinetic...
- Severe CFrC as determined by study team
- Prior tenapanor usage
- Hospitalization within 4-weeks prior to study initiation.
- DIOS within 4-weeks prior to study initiation.
See the full eligibility criteria
- Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
- Meeting criteria for CFrC Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior:
- Straining in at least 25% of defecations
- Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)
- Sensation of incomplete evacuation more than 25% of defecations
- Sensation of anorectal obstruction/blockage more than 25% of defecations
- Manual disimpaction/manipulation of pelvic floor to facilitate more than 25% of defecations
- Fewer than 3 spontaneous bowel movements weekly (change in stool frequency)
- Loose stools rarely present without the use of laxatives
- Willingness to avoid major dietary or lifestyle changes during study.
- Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is to be allowed)
- Inability to discontinue standing bowel regimen (including fiber, stool softener, as well as either osmotic or stimulant laxative, pro-kinetic serotonergic agents, or other therapy) 2-weeks prior to study drug...
- Severe CFrC as determined by study team
- Prior tenapanor usage
- Hospitalization within 4-weeks prior to study initiation.
- DIOS within 4-weeks prior to study initiation.
- Other known/suspected mechanical obstruction
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.