Cystic FibrosisPhase 4NCT05069597

Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

A Phase 4 study testing CREON in people with Cystic Fibrosis and Chronic Pancreatitis, run by AbbVie at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cystic Fibrosis, Chronic Pancreatitis
What is being tested?: CREON
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 21 sitesUnited States
Study dates: 14 Oct 2021to 28 Aug 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Who cannot join

Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Albany Medical College-Pulmonary /ID# 250041
Albany, New York, 12208-3504
University of Cincinnati /ID# 229511
Cincinnati, Ohio, 45267-0585
UH Cleveland Medical Center /ID# 246065
Cleveland, Ohio, 44106
Cleveland Clinic Main Campus /ID# 245864
Cleveland, Ohio, 44195
The Curators of the University of Missouri /ID# 233331
Columbia, Missouri, 65211
University of Florida - Archer /ID# 233411
Gainesville, Florida, 32610
Baylor College of Medicine Medical Center /ID# 233441
Houston, Texas, 77030-4202
Dartmouth-Hitchcock Medical Center /ID# 231633
Lebanon, New Hampshire, 03756
Valley Children's Hospital /ID# 231452
Madera, California, 93636
Atlantic Medical Research /ID# 239568
Margate, Florida, 33063-5737
University of Miami, Miller School of Medicine /ID# 239415
Miami, Florida, 33136
Velocity Clinical Research /ID# 231076
Mobile, Alabama, 36608-1771
West Virginia University Hospitals /ID# 239593
Morgantown, West Virginia, 26506
Asr, Llc /Id# 239566
Nampa, Idaho, 83687
GI Pros /ID# 239486
Naples, Florida, 34102-5449
NYU Langone Health /ID# 233417
New York, New York, 10016-2708
Central FL Pulmonary Orlando /ID# 245863
Orlando, Florida, 32803
Univ Texas HSC San Antonio /ID# 239060
San Antonio, Texas, 78229-3901
Options Health Research, LLC /ID# 239535
Tulsa, Oklahoma, 74104
Wake Forest Baptist Health /ID# 229537
Winston-Salem, North Carolina, 27157-0001
UMass Chan Medical School /ID# 230476
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient

Creon is an approved drug for the treatment of EPI. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States.

Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days.

Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Conditions: Cystic Fibrosis, Chronic Pancreatitis
Being tested: CREON
Keywords: Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase
Medical subject headings: Cystic Fibrosis, Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CREONDrug
Also called Pancrelipase
Capsule; Oral

Study groups in NCT05069597
Study group	Role	What they receive
Run-in Period: Creon-ABT	Experimental	Participants will receive Creon-ABT daily for 28 days. Receives: Drug: CREON
Treatment Period: Creon-AAPIS	Experimental	Participants will receive Creon-AAPIS daily for 85 days. Receives: Drug: CREON

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Measured: Day 1 (baseline), 8, 15, 29, and 85
Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Measured: Day 1 (Baseline), 8, 15, 29, and 85
Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Measured: Day 1 (Baseline), 8, 15, 29, and 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202128 Aug 2023

First posted6 Oct 2021
Study start14 Oct 2021
Primary completion7 Jul 2023
Study completion28 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
More trials run by AbbVieThe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05069597
Sponsor's protocol ID: M21-432
Status last verified: Jun 2024
First submitted: 27 Sep 2021
Last updated: 23 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient
ClinicalTrials.gov ID: NCT05069597
Acronym / sponsor ID: M21-432
Conditions: Cystic Fibrosis, Chronic Pancreatitis
Keywords: Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 14 Oct 2021 (actual)
Primary completion: 7 Jul 2023 (actual)
Study completion: 28 Aug 2023 (actual)
First posted: 6 Oct 2021 (actual)
Results: Posted 23 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Run-in Period: Creon-ABT	Experimental	Drug: CREONParticipants will receive Creon-ABT daily for 28 days.
Treatment Period: Creon-AAPIS	Experimental	Drug: CREONParticipants will receive Creon-AAPIS daily for 85 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Key exclusion criteria (1 listed)

Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

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
CREONAlso: PancrelipaseCapsule; Oral	Drug	Run-in Period: Creon-ABT, Treatment Period: Creon-AAPIS

Primary outcome

Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
Time frame: Day 1 (baseline), 8, 15, 29, and 85
The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
Time frame: Day 1 (Baseline), 8, 15, 29, and 85
The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.
Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85
Time frame: Day 1 (Baseline), 8, 15, 29, and 85
The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.

Results and safety

Results posted to the registry on 23 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Run-in: Creon-ABT	30	30
Treatment: Creon-AAPIS	0	0

Primary outcome: Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

Time frame: Day 1 (baseline), 8, 15, 29, and 85. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment: Creon-AAPIS n = 29
Change from Baseline to Day 8	0.0012 (0.2953)
Change from Baseline to Day 15	0.0480 (0.4354)
Change from Baseline to Day 29	0.1506 (0.5396)
Change from Baseline to Day 85	0.0791 (0.5298)

Population analysed: The Per Protocol Population included all enrolled subjects who received at least 1 dose of study drug of Creon-AAPIS, had Day 1 (Baseline) PEI-Q scores collected, and had at least one post-baseline PEI-Q scores collected during the Treatment Period (Days 8, 15, 29, and 85). The pharmacodynamic endpoints were analyzed in the Per Protocol Population. Number analyzed indicates the number of participants with data available for analysis at specified timepoint.

Primary outcome: Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

Time frame: Day 1 (Baseline), 8, 15, 29, and 85. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment: Creon-AAPIS n = 29
Change from baseline to Day 8	0.0582 (0.3722)
Change from baseline to Day 15	0.0530 (0.4605)
Change from baseline to Day 29	0.1905 (0.6100)
Change from baseline to Day 85	0.0893 (0.5190)

Primary outcome: Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

Time frame: Day 1 (Baseline), 8, 15, 29, and 85. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment: Creon-AAPIS n = 29
Change from Baseline to Day 8	-0.0555 (0.3235)
Change from Baseline to Day 15	0.0432 (0.5240)
Change from Baseline to Day 29	0.1111 (0.5565)
Change from Baseline to Day 85	0.0695 (0.7000)

Adverse events

Time frame: All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 28 days for CREON-ABT and 116 days for CREON-AAPIS.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-in: Creon-ABT	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
Treatment: Creon-AAPIS	2 of 29 (6.9%)	9 of 29 (31%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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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.

ABBVIE INC. study director

AbbVie

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CREON in people with Cystic Fibrosis and Chronic Pancreatitis, run by AbbVie at 21 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 (time frame: Day 1 (baseline), 8, 15, 29, and 85). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05069597.

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 23 Jul 2024.