Pancreatic Exocrine Insufficiency Due to Cystic FibrosisPhase 3NCT02137382
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
A Phase 3 study testing Creon® and Creon N in people with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis, run by Abbott at 7 sites in 2 countries.
Trial summary
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- What is being tested?
- Creon® and Creon N
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2014to Aug 2014
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
- Age ≥ 12 years
- Subjects who are able to swallow capsules with each meal and snacks
- Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis
- Diagnosis of pancreatic exocrine insufficiency proven by:
- Coefficient of fat absorption (CFA) < 70% without supplementation
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- or Human fecal elastase < 50 μg/g stool
- Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
- Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
- Stable body weight defined as no more than a 5% decline within 3 months of enrolment
- Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.
Who cannot join
- Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study
- History of acute abdomen
- History of fibrosing colonopathy
- History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
- Solid organ transplant or surgery affecting the large bowel other than appendectomy
- Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy)
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- Pregnancy or lactation
- Any type of malignancy involving the digestive tract in the last 5 years
- Celiac disease or Crohn's disease
- Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules
- Suspected non-compliance or non-cooperation
- Intake of experimental drugs within 30 days prior to study start
- Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study
- Diagnosis of human immunodeficiency virus in medical history.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Hungary4 sites
Research facility ID ORG-000826
Budapest, 1122
Research facility ID ORG-000816
Debrecen, 4031
Research facility ID ORG-000827
Kaposvár, 7400
Research facility ID ORG-000825
Törökbálint, 2045
Spain3 sites
Research facility ID ORG-000829
Barcelona, 8035
Research facility ID ORG-000828
Seville, 41013
Research facility ID ORG-000815
Valencia, 46026
About this study
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
- Being tested
- Creon®, Creon N
- Keywords
- maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creon®Drug
active comparator
Creon NDrug
experimental drug
| Study group | Role | What they receive |
|---|---|---|
| Creon N, then Creon® | Experimental | Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. Receives: Drug: Creon® |
| Creon® , then Creon N | Experimental | Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. Receives: Drug: Creon N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of Fat Absorption (CFA)
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake
Measured: 5 days
Secondary outcomes (6)
Coefficient of Nitrogen Absorption (CNA).
CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)
Measured: 5 days
Total Fat Excretion
Total amount of fat excreted during the stool collection period in grams.
Measured: 5 days
Stool Frequency
Stool frequency is the average of the daily number of stools recorded during the treatment period
Measured: 5 days
Percentage of Days With no Flatulence
The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary).
Measured: 5 days
Percentage of Days With no Abdominal Pain
The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary).
Measured: 5 days
Percentage of Days With Formed/Normal Stools
The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Exocrine Insufficiency Due to Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suntje Sander-Struckmeier, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137382
- Sponsor's protocol ID
- PANC3004
- Other IDs
- 2013-002819-10
- Status last verified
- Jan 2016
- First submitted
- 12 Feb 2014
- Last updated
- 22 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
PubMed 32761612
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02137382
- Acronym / sponsor ID
- PANC3004
- Keywords
- maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Posted 27 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creon N, then Creon® | Experimental | Drug: Creon®Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. |
| Creon® , then Creon N | Experimental | Drug: Creon NSubjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
- Age ≥ 12 years
- Subjects who are able to swallow capsules with each meal and snacks
- Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis
- Diagnosis of pancreatic exocrine insufficiency proven by:
Key exclusion criteria (14 listed)
- Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study
- History of acute abdomen
- History of fibrosing colonopathy
- History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
- Solid organ transplant or surgery affecting the large bowel other than appendectomy
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 |
|---|---|---|
| Creon®active comparator | Drug | Creon N, then Creon® |
| Creon Nexperimental drug | Drug | Creon® , then Creon N |
Primary outcome
Coefficient of Fat Absorption (CFA)
Time frame: 5 days
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake
6 secondary outcomes
Coefficient of Nitrogen Absorption (CNA).
Time frame: 5 days
Total Fat Excretion
Time frame: 5 days
Stool Frequency
Time frame: 5 days
Percentage of Days With no Flatulence
Time frame: 5 days
Percentage of Days With no Abdominal Pain
Time frame: 5 days
Percentage of Days With Formed/Normal Stools
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32761612Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
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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.
Suntje Sander-Struckmeier, PhD study director
Abbott
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Creon® and Creon N in people with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis, run by Abbott at 7 sites in 2 countries.
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 14 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Hungary, Spain. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2015). 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?
Coefficient of Fat Absorption (CFA) (time frame: 5 days). 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 NCT02137382, which also lists 1 linked publication.
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 22 Jan 2016.