Equivalence Study to Compare Two Strengths of Creon in China (CREON)
Primary Purpose
Pancreatic Insufficiency
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Creon® 25000
Creon® 10000
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Insufficiency
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Shanghai Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Creon® 25000 then Creon® 10000
Creon® 10000 then Creon® 25000
Arm Description
Pancreatic enzyme
Pancreatic enzyme
Outcomes
Primary Outcome Measures
Coefficient of fat absorption
Secondary Outcome Measures
fat intake - fat excretion/fat intake x 100
stool weight
Clinical symptomatology
stool frequency, stool consistency, abdominal pain, flatulence
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03450772
Brief Title
Equivalence Study to Compare Two Strengths of Creon in China
Acronym
CREON
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Creon® 25000 then Creon® 10000
Arm Type
Experimental
Arm Description
Pancreatic enzyme
Arm Title
Creon® 10000 then Creon® 25000
Arm Type
Active Comparator
Arm Description
Pancreatic enzyme
Intervention Type
Drug
Intervention Name(s)
Creon® 25000
Intervention Description
Experimental drug
Intervention Type
Drug
Intervention Name(s)
Creon® 10000
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
Coefficient of fat absorption
Time Frame
5 days
Secondary Outcome Measure Information:
Title
fat intake - fat excretion/fat intake x 100
Time Frame
5 days
Title
stool weight
Time Frame
5 days
Title
Clinical symptomatology
Description
stool frequency, stool consistency, abdominal pain, flatulence
Time Frame
5 days and 24 weeks
Title
Subject's acceptance of treatment and preference
Description
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
Time Frame
5 days and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suntje Sander, PhD
Phone
+495116750
Ext
3254
Email
suntje.sander@abbott.com
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhaoshen, Prof
12. IPD Sharing Statement
Learn more about this trial
Equivalence Study to Compare Two Strengths of Creon in China
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