Pancreatic InsufficiencyPhase 2/3NCT01012908
Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
A Phase 2/3 study testing Norzyme - Bergamo and Creon in people with Pancreatic Insufficiency, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of… 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?
- Norzyme - Bergamo and Creon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Jun 2011
- Phase
- Phase 2/3
- 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
- Patients must agree with the purposes of the study and sign the Informed Consent in two ways;
- Be aged over 18 years;
- Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease;
- Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals;
- Agree to record daily food intake in phase 2 and repeat the diet in phase 3;
- Present ability to meet the patient's diary;
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- Be clinically compensated with replacement therapy;
- Must be admitted patients in both the sexes;
- Must be accepted patients of any ethnicity.
Who cannot join
- Cystic fibrosis;
- Acute pancreatitis;
- Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study;
- Diabetes decompensated;
- Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study;
- Any type of treatment for morbid obesity;
- Abusive use of alcohol in the three months preceding the study;
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
About this study
The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.
Read the detailed description
As a secondary objective will be assessed the following parameters:
- Incidence of abdominal pain;
- Frequency of flatus;
- Frequency of bowel movements during the treatment;
- Consistency of stools during treatment;
- Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.
- Conditions
- Pancreatic Insufficiency
- Being tested
- Norzyme - Bergamo, Creon
- 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.
Norzyme - BergamoDietary supplement
2 - 8 tablets per day.
CreonDietary supplement
2 - 8 tablets pet day
| Study group | Role | What they receive |
|---|---|---|
| Norzyme | Experimental | Pancreatic Enzymes - Norzyme (Bergamo) Receives: Dietary Supplement: Norzyme - Bergamo |
| Creon (Solvay) | Active comparator | Pancreatic Enzymes - Creon (Solvay) Receives: Dietary Supplement: Creon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of fat in the stools of 72 hours of medication use between the two treatments.
Measured: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day
Secondary outcomes (5)
Frequency of bowel movements per day
Measured: First period: days 1 - 14. Second period: days 1-14. (every day)
Consistency and characteristics of feces
Measured: First period: days 1 - 14. Second period: days 1-14. (every day)
Frequency and intensity of abdominal pain daily
Measured: First period: days 1 - 14. Second period: days 1-14. (every day)
Frequency of flatulence daily
Measured: First period: days 1 - 14. Second period: days 1-14. (every day)
Amount of drug used in treatment
Measured: First period: days 1 - 14. Second period: days 1-14. (every day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionApr 2010 (estimated)
- Study completionJun 2011 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012908
- Sponsor's protocol ID
- PANBER0609
- Status last verified
- Nov 2009
- First submitted
- 11 Nov 2009
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
- ClinicalTrials.gov ID
- NCT01012908
- Acronym / sponsor ID
- PANBER0609
- Conditions
- Pancreatic Insufficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 13 Nov 2009 (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.
The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.
Detailed description
As a secondary objective will be assessed the following parameters:
- Incidence of abdominal pain;
- Frequency of flatus;
- Frequency of bowel movements during the treatment;
- Consistency of stools during treatment;
- Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norzyme | Experimental | Dietary Supplement: Norzyme - BergamoPancreatic Enzymes - Norzyme (Bergamo) |
| Creon (Solvay) | Active comparator | Dietary Supplement: CreonPancreatic Enzymes - Creon (Solvay) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must agree with the purposes of the study and sign the Informed Consent in two ways;
- Be aged over 18 years;
- Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease;
- Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals;
- Agree to record daily food intake in phase 2 and repeat the diet in phase 3;
Key exclusion criteria (8 listed)
- Cystic fibrosis;
- Acute pancreatitis;
- Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study;
- Diabetes decompensated;
- Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study;
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 |
|---|---|---|
| Norzyme - Bergamo2 - 8 tablets per day. | Dietary supplement | Norzyme |
| Creon2 - 8 tablets pet day | Dietary supplement | Creon (Solvay) |
Primary outcome
Amount of fat in the stools of 72 hours of medication use between the two treatments.
Time frame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day
5 secondary outcomes
Frequency of bowel movements per day
Time frame: First period: days 1 - 14. Second period: days 1-14. (every day)
Consistency and characteristics of feces
Time frame: First period: days 1 - 14. Second period: days 1-14. (every day)
Frequency and intensity of abdominal pain daily
Time frame: First period: days 1 - 14. Second period: days 1-14. (every day)
Frequency of flatulence daily
Time frame: First period: days 1 - 14. Second period: days 1-14. (every day)
Amount of drug used in treatment
Time frame: First period: days 1 - 14. Second period: days 1-14. (every day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Norzyme - Bergamo and Creon in people with Pancreatic Insufficiency, 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 9 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: status not confirmed, as of the sponsor's last update on 28 Oct 2010. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Amount of fat in the stools of 72 hours of medication use between the two treatments. (time frame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day). 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 28 Oct 2010.