Phase 3 Cystic Fibrosis Trial, Recruiting NCT06810167 Sponsor: Massachusetts General Hospital Condition: Cystic Fibrosis
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Phase 3 Cystic Fibrosis Trial, Recruiting

NCT06810167
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with cystic fibrosis, confirmed either through a sweat chloride test or genetic testing.
  • People who have cystic fibrosis-related constipation (CFrC), meaning they have experienced at least 2 of the following symptoms for at least 3 months, with those symptoms starting at least 6 months before joining the trial: needing to strain during more than 1 in 4 bowel movements; passing hard or lumpy stools more than 25% of the time; feeling like the bowel hasn't fully emptied more than 25% of the time; feeling a blockage in the back passage more than 25% of the time; needing to use hands or press on the pelvic floor to help pass a stool more than 25% of the time; having fewer than 3 bowel movements per week; or rarely having soft stools unless laxatives are used.
  • People who are willing to avoid making major changes to their diet or lifestyle during the study.

Who may not be able to join:

  • People who have taken antibiotics to treat an infection in the 4 weeks before the study starts (note: regular low-dose azithromycin taken 3 times a week for lung health is allowed — confirm with trial site).
  • People who are unable to stop their regular bowel treatments — such as fibre supplements, stool softeners, laxatives, or gut-motility medicines — for 2 weeks before starting the study drug (limited use of osmotic laxatives as a rescue option only may be permitted — confirm with trial site).
  • People whose cystic fibrosis-related constipation is considered severe by the study team.
  • People who have previously used a medicine called tenapanor.
  • People who have been hospitalised in the 4 weeks before the study starts.
  • People who have had a serious bowel blockage known as distal intestinal obstruction syndrome (DIOS) in the 4 weeks before the study starts.
  • People who have another known or suspected physical blockage in the bowel.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Christoher D Velez, MD, Massachusetts General Hospital

Phone: 6176437088

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Increase in SBM frequency

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov