Chronic PancreatitisPhase 3NCT00414908
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
A Phase 3 study testing Pancrelipase delayed release capsule in people with Chronic Pancreatitis and Pancreatectomy, run by Solvay Pharmaceuticals at 30 sites in 8 countries.
Trial summary
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
- What is being tested?
- Pancrelipase delayed release capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 30 sitesin 8 countries
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
- Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
- Total stool fat > 40 g over 4 days (using Van De Kamer method)
- Proven chronic pancreatitis
- Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Who cannot join
- Ileus or acute abdomen
- Any type of malignancy involving the digestive tract in the last 5 years
- Presence of pseudo-pancreatic cyst ≥ 4
- Continued excessive intake of alcohol or drug abuse
- Known infection with HIV
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United States23 sites
Site 2
Ann Arbor, Michigan
Site 6
Atlanta, Georgia
Site 20
Boone, North Carolina
Site 3
Boston, Massachusetts
Site 22
Bristol, Connecticut
Site 8
Cedar Knolls, New Jersey
Site 17
Chicago, Illinois
Site 10
Cincinnati, Ohio
Site 11
Cleveland, Ohio
Site 13
Dallas, Texas
Site 29
Grand Rapids, Michigan
Site 14
Indianapolis, Indiana
Site 15
Kansas City, Kansas
Site 16
Lexington, Kentucky
Site 30
Maywood, Illinois
Site 12
New Orleans, Louisiana
Site 21
Pittsburgh, Pennsylvania
Site 18
Richmond, Virginia
Site 4
Rutherford College, North Carolina
Site 9
Scottsdale, Arizona
Site 5
St Louis, Missouri
Site 7
Tampa, Florida
Site 1
Tupelo, Mississippi
About this study
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.
- Being tested
- Pancrelipase delayed release capsule, Placebo Comparator
- Keywords
- Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancrelipase delayed release capsuleDrug
24,000 unit capsule
Placebo ComparatorDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Pancrelipase delayed release capsule |
| B | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.
Change is calculated as (DB CFA-Baseline CFA).
Measured: End of double-blind period (5-7 days)
Secondary outcomes (7)
Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.
The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).
Measured: End of double-blind period (5-7 days)
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.
Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).
Measured: End of double-blind period (5-7 days)
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.
Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).
Measured: End of double-period (5-7 days)
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period
Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).
Measured: End of double-period (5-7 days)
Abdominal Pain at the End of the Double-blind Period.
4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).
Measured: End of double-period (5-7 days)
Stool Consistency at the End of the Double-blind Period
4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).
Measured: End of double-period (5-7 days)
Flatulence at the End of Double-blind Period
4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).
Measured: End of double-period (5-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionDec 2009
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 Chronic PancreatitisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414908
- Sponsor's protocol ID
- S245.3.124
- Other IDs
- 2004-000227-15, 2004
- Status last verified
- Aug 2011
- First submitted
- 21 Dec 2006
- Last updated
- 10 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
- ClinicalTrials.gov ID
- NCT00414908
- Acronym / sponsor ID
- S245.3.124
- Keywords
- Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Posted 16 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Pancrelipase delayed release capsule |
| B | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
- Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
- Total stool fat > 40 g over 4 days (using Van De Kamer method)
- Proven chronic pancreatitis
- Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Key exclusion criteria (5 listed)
- Ileus or acute abdomen
- Any type of malignancy involving the digestive tract in the last 5 years
- Presence of pseudo-pancreatic cyst ≥ 4
- Continued excessive intake of alcohol or drug abuse
- Known infection with HIV
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 |
|---|---|---|
| Pancrelipase delayed release capsule24,000 unit capsule | Drug | A |
| Placebo ComparatorPlacebo | Drug | B |
Primary outcome
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
Time frame: End of double-blind period (5-7 days)
The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).
7 secondary outcomes
Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.
Time frame: End of double-blind period (5-7 days)
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.
Time frame: End of double-blind period (5-7 days)
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.
Time frame: End of double-period (5-7 days)
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period
Time frame: End of double-period (5-7 days)
Abdominal Pain at the End of the Double-blind Period.
Time frame: End of double-period (5-7 days)
Stool Consistency at the End of the Double-blind Period
Time frame: End of double-period (5-7 days)
Flatulence at the End of Double-blind Period
Time frame: End of double-period (5-7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pancrelipase delayed release capsule in people with Chronic Pancreatitis and Pancreatectomy, run by Solvay Pharmaceuticals at 30 sites in 8 countries.
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 5 inclusion and 5 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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Bulgaria, Poland, Puerto Rico, Russia and 3 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2009). 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?
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. (time frame: End of double-blind period (5-7 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 10 Aug 2011.