Cystic FibrosisPhase 3NCT06810167
Assessing Tenapanor as a Treatment of CF-related Constipation.
A Phase 3 study testing Tenapanor in people with Cystic Fibrosis and Constipation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cystic Fibrosis, Constipation
- What is being tested?
- Tenapanor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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 initiation (with ability to use osmotic laxative therapy as rescue therapy only).
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.
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. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.
- Conditions
- Cystic Fibrosis, Constipation
- Being tested
- Tenapanor
- Keywords
- Constipation, Cystic Fibrosis, CFrC
- Medical subject headings
- Cystic Fibrosis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis patients with CF-related constipation | Experimental | Not described Receives: Drug: Tenapanor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in SBM frequency
There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.
Measured: Patients will record SBM frequency over the 4-week treatment period.
Secondary outcomes (3)
Change in PAC-SYM questionnaire score
There will be a change (with use of descriptive statistics) in bowel symptoms characterized by the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire with tenapanor administration. PAC-SYM is a PRO previously used to examine constipation in pwCF. A decreased score corresponds to improvement of bowel symptoms.
Measured: Patients will complete the PAC-SYM at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in PAC-QOL questionnaire score
There will be a change (with use of descriptive statistics) in bowel symptoms characterized by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire with tenapanor administration. PAC-QOL is a PRO previously used to examine constipation in pwCF. A decreased score corresponds to improvement of bowel symptoms.
Measured: Patients will complete the PAC-QOL at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in IBS-SSS questionnaire score
There will be a 50-point change in the Irritable Bowel Syndrome Scoring System - IBS-SSS (in line with recent bowel distress related literature Ford AC, Wright-Hughes A, Alderson SLet al Lancet 2023) in pwCF and CFrC receiving tenapanor.
Measured: Patients will complete the IBS-SSS at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jun 2025
- Primary completion15 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ardelyx
- Responsible party
- Principal investigator, Christopher Velez, Massachusetts General Hospital
- Investigators
- Christoher D Velez, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810167
- Sponsor's protocol ID
- 2024P002058
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.
- ClinicalTrials.gov ID
- NCT06810167
- Acronym / sponsor ID
- 2024P002058
- Conditions
- Cystic Fibrosis, Constipation
- Keywords
- Constipation, Cystic Fibrosis, CFrC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ardelyx
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis patients with CF-related constipation | Experimental | Drug: Tenapanor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Willingness to avoid major dietary or lifestyle changes during study.
Key exclusion criteria (7 listed)
- 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 initiation (with ability to use osmotic laxative therapy as rescue therapy only).
- Severe CFrC as determined by study team
- Prior tenapanor usage
- Hospitalization within 4-weeks prior to study initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenapanorCF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks. | Drug | Cystic fibrosis patients with CF-related constipation |
Primary outcome
Increase in SBM frequency
Time frame: Patients will record SBM frequency over the 4-week treatment period.
There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.
3 secondary outcomes
Change in PAC-SYM questionnaire score
Time frame: Patients will complete the PAC-SYM at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in PAC-QOL questionnaire score
Time frame: Patients will complete the PAC-QOL at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in IBS-SSS questionnaire score
Time frame: Patients will complete the IBS-SSS at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoher D Velez, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenapanor in people with Cystic Fibrosis and Constipation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in SBM frequency (time frame: Patients will record SBM frequency over the 4-week treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.