Pancreatic InsufficiencyPhase 3CREONNCT03450772
Equivalence Study to Compare Two Strengths of Creon in China
A Phase 3 study testing Creon® 25000 and Creon® 10000 in people with Pancreatic Insufficiency, run by Abbott at 1 site in China.
Trial summary
This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Insufficiency
- What is being tested?
- Creon® 25000 and Creon® 10000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2017to 30 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Signed informed consent
- Subjects ≥ 18 years
- A) Chronic pancreatitis must be documented in the medical file by at least one of the following methods:
- Imaging techniques (ultrasound, CT, MRI, or endoscopic ultrasound)
- ERCP (endoscopic retrograde cholangiopancreatography)
- Plain film of the abdomen with pancreatic calcification or
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- B) Partial or total pancreatectomy ≥ 30 days prior to enrollment and without current postsurgery complications
- PEI proven by human fecal elastase ≤ 100 µg/g stool (during the screening period)
- Subjects without Creon (Pancreatin Enteric Coated Minimicrospheres) intake in the past three months
- 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 (e.g. Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past three 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
- Subjects with a history of fibrosing colonopathy
- Solid organ transplant
- Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
- Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
- Subjects with recurrent malignant tumors of any kind
- Use of an immunosuppressive drug or chemotherapy
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- Acute phase of pancreatitis
- Acute phase of pancreatitis
- Subjects who are not able or willing to ingest 90g fat/day (± 10 g fat/day) during the cross-over periods or are not willing to collect complete stools during the demarcation period.
- Subjects in an instable condition after pancreatic surgery (Karnofsky index < 70)
- Known infection with HIV
- Pregnancy or lactation
- Current excessive alcohol intake or drug abuse
- Investigational drug intake within prior 30 days
- Known allergy against pancreatin of porcine origin or to any of the excipients of Pancreatin Enteric-Coated Capsules
- Suspected non-compliance or non-cooperation
- Celiac disease, Crohn´s disease
- Ileus or acute abdomen in the medical history
- Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject's participation in or to complete the study
- Any acute or chronic disease (i.e infectious diseases) which may limit the hospitalization, dietary adherence or stool collection or completion of the study procedures
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai
Li Zhaoshen, Prof
About this study
Official title: Open-label, Multicenter, Randomized, Cross-Over, Equivalence Study to Compare the Efficacy and Safety of Two Strengths of Pancreatin Enteric-Coated Capsules in Pancreatic Exocrine Insufficiency in Chinese Subjects
This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.
- Conditions
- Pancreatic Insufficiency
- Being tested
- Creon® 25000, Creon® 10000
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creon® 25000Drug
Experimental drug
Creon® 10000Drug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Creon® 25000 then Creon® 10000 | Experimental | Pancreatic enzyme Receives: Drug: Creon® 25000 |
| Creon® 10000 then Creon® 25000 | Active comparator | Pancreatic enzyme Receives: Drug: Creon® 10000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of fat absorption
Measured: 5 days
Secondary outcomes (4)
fat intake - fat excretion/fat intake x 100
Measured: 5 days
stool weight
Measured: 5 days
Clinical symptomatology
stool frequency, stool consistency, abdominal pain, flatulence
Measured: 5 days and 24 weeks
Subject's acceptance of treatment and preference
Subject's acceptance of treatment will be judged based on the following scale: very good, good, moderate and unsatisfactory.
Which treatment did you prefer? No difference between treatment 1 and treatment 2 Treatment 1 is better than treatment 2 Treatment 2 is better than treatment 1
Measured: 5 days and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start31 Aug 2017
- Primary completionApr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic InsufficiencyStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450772
- Sponsor's protocol ID
- PANC3016
- Acronym
- CREON
- Status last verified
- Nov 2021
- First submitted
- 15 Feb 2018
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Randomized, Cross-Over, Equivalence Study to Compare the Efficacy and Safety of Two Strengths of Pancreatin Enteric-Coated Capsules in Pancreatic Exocrine Insufficiency in Chinese Subjects
- ClinicalTrials.gov ID
- NCT03450772
- Acronym / sponsor ID
- CREON / PANC3016
- Conditions
- Pancreatic Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 1 Mar 2018 (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.
This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creon® 25000 then Creon® 10000 | Experimental | Drug: Creon® 25000Pancreatic enzyme |
| Creon® 10000 then Creon® 25000 | Active comparator | Drug: Creon® 10000Pancreatic enzyme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent
- Subjects ≥ 18 years
- A) Chronic pancreatitis must be documented in the medical file by at least one of the following methods:
- B) Partial or total pancreatectomy ≥ 30 days prior to enrollment and without current postsurgery complications
- PEI proven by human fecal elastase ≤ 100 µg/g stool (during the screening period)
Key exclusion criteria (20 listed)
- Subjects with a history of fibrosing colonopathy
- Solid organ transplant
- Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
- Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
- Subjects with recurrent malignant tumors of any kind
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® 25000Experimental drug | Drug | Creon® 25000 then Creon® 10000 |
| Creon® 10000Active comparator | Drug | Creon® 10000 then Creon® 25000 |
Primary outcome
Coefficient of fat absorption
Time frame: 5 days
4 secondary outcomes
fat intake - fat excretion/fat intake x 100
Time frame: 5 days
stool weight
Time frame: 5 days
Clinical symptomatology
Time frame: 5 days and 24 weeks
Subject's acceptance of treatment and preference
Time frame: 5 days and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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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.
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 Creon® 25000 and Creon® 10000 in people with Pancreatic Insufficiency, run by Abbott at 1 site in China.
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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suntje Sander, PhD (+495116750 ext. 3254, suntje.sander@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of fat absorption (time frame: 5 days). 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 24 Nov 2021.