Chronic Renal FailurePhase 3NCT01228643
Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs
A Phase 3 study testing Pancreatic enzimes and Creon ® in people with Chronic Renal Failure, run by Azidus Brasil at 1 site in Brazil.
Trial summary
Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with pancreatic insufficiency Exogenous any cause. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Pancreatic enzimes and Creon ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2007to Dec 2011
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participation in any study or have ingested some experimental drug trial in the 3 months preceding the study.
- Regular use of medication that interferes with the action of the drug test:
- in the 4 weeks preceding the study or make use of any medications that interfere with drug test a week before the start the study.
- Patients who take any kind of treatment for morbid obesity.
- Cases of stomach reduction surgery.
- Cases of surgical reduction of the intestine.
- Present history of current abuse of alcohol or have drunk alcohol in the 48 hours prior to the study.
- Have any condition which prevents him from participating in the study, for trial Principal Investigator.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clinica Pesquisa e Desenvolvimento LTDA
Valinhos, São Paulo, 13271000
About this study
Official title: Study Of Effectiveness Of The Use Of Pancreatic Enzyme: Norzyme® -(Made In The Laboratory Pancrealipase Bergamo) Inpatients With Pancreatic Insufficiency In Use Substituteenzymatic When Compared To Product Creon®
Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay Farma Ltda.
Read the detailed description
Phase III clinical trial systematic sampling, double-blind, randomized, crossed that evaluates the comparative efficacy of a formulation containing enzyme pancreas in 16 patients with pancreatic insufficiency exogenous of any cause. The study will be conducted with the inclusion of 16 adult patients, both sexes, regardless of color or social class, aged 14 to 65 years, clinically diagnosed as having pancreatic insufficiency exocrine any etiology (cystic fibrosis, cancer, pancreatectomy, Surgery by trauma). The Research Subjects will be recruited with the help of medical coinvestigador specialist Dr. Francisco Callejas Neto, who will offer their clinic patients to participate in the study. If there is interest from same, all are invited to attend the Clinic for total LAL clarification about the study of drug action, benefits, possible risks, compensation, study period, and finally understanding reading and signing together with the investigator of the Term of Consent.
The research subjects will have complete freedom to lead to the Informed Consent house, where they can review all items easy. After informed and the consent form and signed informed, patients will be examined by the researcher LAL Clinic which will perform a physical examination in the same general and specific. Will rated their personal background and reviewed the Inclusion and Excluded from the study.
Satisfying the criteria for inclusion in the study subjects are approved to participate in the study.
The 16 Subjects Research approved within the inclusion criteria and exclusion to participate in the study be included in the study as sequential by the number of their care. Later, the same will be inserted in randomization table, which was outlined in a randomized crossover for two drugs, the randomization scheme will be in the balanced cross 2 x 2. A design is said to be balanced if it satisfies the following conditions:
- Each medication is applied only once in each subject;
- in each period, the number of subjects receiving each medicine must be equal; This randomization was previously performed by the computer program and by a qualified professional Prof. Dr. Yuko Wada Cilicia (PhD in Biostatistics and PhD of Biostatistics, UNICAMP) of Statpharm Scientific Consulting Ltda.
All study medication will be labeled according to the randomization, previously performed by pharmacy LAL Clinica, which should make conference material for 3 checks. In each period of the study medication should be labeled with the following words: code of the subject during the study period and dose to be administered in the same. All these procedures should be made to minimize and avoid bias in the study.
- Conditions
- Chronic Renal Failure
- Being tested
- Pancreatic enzimes, Creon ®
- Keywords
- Pancreatic enzymes., To evaluate the efficacy of drugs in chronic renal failure
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic enzimesBiological
- Norzyme ® (product testing) composition: 20.000USP lipase, 65.000USP of 65.000USP amylase and protease.
Creon ®Device
- Creon ® (reference product) composition: 25.000UI lipase, amylase 74.700UI 62.500UI and protease
| Study group | Role | What they receive |
|---|---|---|
| Norzyme® | Experimental | Not described Receives: Biological: Pancreatic enzimes |
| Creon® | Active comparator | Not described Receives: Device: Creon ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance of fat in feces.
Measured: 06 weeks of treatment.
Secondary outcomes (1)
Prove the efficacy of pancreatic enzyme Norzyme ® through the activity of lipase in the formulation contained in the control of steatorrhea
Measured: 06 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startJun 2007
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
- Investigators
- Alexandre Frederico, Doctor, Principal investigator, LAL Clinical Reseach e Development Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228643
- Sponsor's protocol ID
- PANBER0607
- Status last verified
- Nov 2022
- First submitted
- 11 Feb 2008
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of Effectiveness Of The Use Of Pancreatic Enzyme: Norzyme® -(Made In The Laboratory Pancrealipase Bergamo) Inpatients With Pancreatic Insufficiency In Use Substituteenzymatic When Compared To Product Creon®
- ClinicalTrials.gov ID
- NCT01228643
- Acronym / sponsor ID
- PANBER0607
- Conditions
- Chronic Renal Failure
- Keywords
- Pancreatic enzymes., To evaluate the efficacy of drugs in chronic renal failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 26 Oct 2010 (estimated)
- 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.
Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay Farma Ltda.
Detailed description
Phase III clinical trial systematic sampling, double-blind, randomized, crossed that evaluates the comparative efficacy of a formulation containing enzyme pancreas in 16 patients with pancreatic insufficiency exogenous of any cause. The study will be conducted with the inclusion of 16 adult patients, both sexes, regardless of color or social class, aged 14 to 65 years, clinically diagnosed as having pancreatic insufficiency exocrine any etiology (cystic fibrosis, cancer, pancreatectomy, Surgery by trauma). The Research Subjects will be recruited with the help of medical coinvestigador specialist Dr. Francisco Callejas Neto, who will offer their clinic patients to participate in the study. If there is interest from same, all are invited to attend the Clinic for total LAL clarification about the study of drug action, benefits, possible risks, compensation, study period, and finally understanding reading and signing together with the investigator of the Term of Consent.
The research subjects will have complete freedom to lead to the Informed Consent house, where they can review all items easy. After informed and the consent form and signed informed, patients will be examined by the researcher LAL Clinic which will perform a physical examination in the same general and specific. Will rated their personal background and reviewed the Inclusion and Excluded from the study.
Satisfying the criteria for inclusion in the study subjects are approved to participate in the study.
The 16 Subjects Research approved within the inclusion criteria and exclusion to participate in the study be included in the study as sequential by the number of their care. Later, the same will be inserted in randomization table, which was outlined in a randomized crossover for two drugs, the randomization scheme will be in the balanced cross 2 x 2. A design is said to be balanced if it satisfies the following conditions:
- Each medication is applied only once in each subject;
- in each period, the number of subjects receiving each medicine must be equal; This randomization was previously performed by the computer program and by a qualified professional Prof. Dr. Yuko Wada Cilicia (PhD in Biostatistics and PhD of Biostatistics, UNICAMP) of Statpharm Scientific Consulting Ltda.
All study medication will be labeled according to the randomization, previously performed by pharmacy LAL Clinica, which should make conference material for 3 checks. In each period of the study medication should be labeled with the following words: code of the subject during the study period and dose to be administered in the same. All these procedures should be made to minimize and avoid bias in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norzyme® | Experimental | Biological: Pancreatic enzimes |
| Creon® | Active comparator | Device: Creon ® |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Participation in any study or have ingested some experimental drug trial in the 3 months preceding the study.
- Regular use of medication that interferes with the action of the drug test:
- in the 4 weeks preceding the study or make use of any medications that interfere with drug test a week before the start the study.
- Patients who take any kind of treatment for morbid obesity.
- Cases of stomach reduction surgery.
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 |
|---|---|---|
| Pancreatic enzimes- Norzyme ® (product testing) composition: 20.000USP lipase, 65.000USP of 65.000USP amylase and protease. | Biological | Norzyme® |
| Creon ®- Creon ® (reference product) composition: 25.000UI lipase, amylase 74.700UI 62.500UI and protease | Device | Creon® |
Primary outcome
Balance of fat in feces.
Time frame: 06 weeks of treatment.
1 secondary outcome
Prove the efficacy of pancreatic enzyme Norzyme ® through the activity of lipase in the formulation contained in the control of steatorrhea
Time frame: 06 weeks of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
Alexandre Frederico, Doctor principal investigator
LAL Clinical Reseach e Development Ltda
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 Pancreatic enzimes and Creon ® in people with Chronic Renal Failure, run by Azidus Brasil at 1 site in Brazil.
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 0 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Nov 2022. 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 Brazil. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Balance of fat in feces. (time frame: 06 weeks of treatment.). 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 3 Nov 2022.