Cystic FibrosisNCT01427712
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
An observational study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, run by Mylan Inc. at 21 sites in Japan.
Trial summary
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases
- What is being tested?
- Pancrelipase
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 21 sitesJapan
- Study dates
- Aug 2011to Mar 2018
- Phase
- Observational
- 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 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Who may be able to join
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis
Who cannot join
- Patients with a history of hypersensitivity to the ingredient of LipaCreon.
- Patients with a history of hypersensitivity to porcine protein
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Site Reference ID/Investigator# 73813
Aichi, 462-8508
Site reference ID/Investigator # 96698
Aichi, 466-8650
Research facility ID ORG-000141
Aichi, 467-8602
Site reference ID/Investigator no. ORG-000842
Aichi, 470-0224
Site reference ID/Investigator # 93736
Aichi, 474-8710
Research facility ORG-000972
Ehime, 794-0006
Mylan investigational site A
Hyōgo, 660-8550
Site reference ID/Investigator # 93735
Ibaraki, 305-8520
Site Reference ID/Investigator# 88673
Ibaraki, 305-8558
Site Reference ID/Investigator# 65529
Ishikawa, 920-8641
Site Reference ID/Investigator# 65530
Kagawa, 760-0017
Site Reference ID/Investigator# 65527
Kagoshima, 890-8520
Mylan investigational site C
Kanagawa, 232-8555
Site Reference ID/Investigator# 65528
Miyagi, 980-0872
Mylan investigational site B
Miyagi, 989-3126
Research facility ID ORG-001138
Ōita, 874-0011
Research facility ID ORG-000594
Osaka, 534-0021
Research facility ORG-000971
Shizuoka, 438-8550
Site reference ID/Investigator# 117495
Tochigi, 329-0431
Research facility no. ORG-001309
Tokyo, 108-8329
Site Reference ID/Investigator# 67122
Tokyo, 157-8535
About this study
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Being tested
- Pancrelipase
- Keywords
- Digestive System Diseases, Cystic Fibrosis, Therapeutic Uses, Gastrointestinal Agents, Pancreatic Diseases, Pancrelipase, Exocrine Pancreatic Insufficiency
- Medical subject headings
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancrelipaseDrug
Also called Lipacreon
| Study group | Role | What they receive |
|---|---|---|
| LipaCreon | In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.
Also, the dose was adjusted appropriately according to the patient's condition. Receives: Drug: Pancrelipase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Drug Reaction
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR).
- Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved.
- Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE
Measured: From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 7 years in the study completers (From date of dosage start, up to 7 years).
Secondary outcomes (14)
Nutritional Endpoints - BMI
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•BMI (height [only prior to the start of Lipacreon treatment] and weight)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutritional Endpoints - Serum Total Protein
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Serum total protein
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Albumin
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Albumin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Total Cholesterol
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Total cholesterol
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Triglycerides
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Triglycerides
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Haemoglobin
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Steatorrhoea (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Frequency of bowel movements (times/day)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Diarrhoea (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Foul stool odour (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Inappetence
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Inappetence (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Degree of General Improvement
Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades:
Improved, unchanged, exacerbated, unassessable
Measured: At 24 weeks
Degree of General Improvement
Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades:
Improved, unchanged, exacerbated, unassessable
Measured: At 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2018
- Study completionMar 2018
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigenori Haruna, Study director, Mylan EPD G.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427712
- Sponsor's protocol ID
- P12-893
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2011
- Last updated
- 10 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We will consider after completion of CSR
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01427712
- Acronym / sponsor ID
- P12-893
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Keywords
- Digestive System Diseases, Cystic Fibrosis, Therapeutic Uses, Gastrointestinal Agents, Pancreatic Diseases, Pancrelipase, Exocrine Pancreatic Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Posted 10 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LipaCreon | – | Drug: PancrelipaseIn general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day. Also, the dose was adjusted appropriately according to the patient's condition. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Key inclusion criteria (1 listed)
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to the ingredient of LipaCreon.
- Patients with a history of hypersensitivity to porcine protein
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 |
|---|---|---|
| PancrelipaseAlso: Lipacreon | Drug | LipaCreon |
Primary outcome
Number of Patients With Adverse Drug Reaction
Time frame: From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 7 years in the study completers (From date of dosage start, up to 7 years).
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR). 1. Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved. 2. Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE
14 secondary outcomes
Nutritional Endpoints - BMI
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutritional Endpoints - Serum Total Protein
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Albumin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Total Cholesterol
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Triglycerides
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Inappetence
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Degree of General Improvement
Time frame: At 24 weeks
Degree of General Improvement
Time frame: At 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. We will consider after completion of CSR
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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.
Shigenori Haruna study director
Mylan EPD G.K.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, run by Mylan Inc. at 21 sites in Japan.
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 1 inclusion and 2 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 10 Jun 2022. 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 Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2022). 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?
Number of Patients With Adverse Drug Reaction (time frame: From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 7 years in the study completers (From date of dosage start, up to 7 years).). 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 10 Jun 2022.