Pancreatic InsufficiencyPhase 3NCT00705978
Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
A Phase 3 study testing Pancreatin in people with Pancreatic Insufficiency, run by Abbott Products at 11 sites in India.
Trial summary
This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA. 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?
- Pancreatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 11 sitesIndia
- Study dates
- Jun 2008to May 2010
- 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 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 a pancreatic function test
- Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
- Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
- Subjects with a pathological stool fat during run in period (> 10g/24 h)
Who cannot join
- Ileus or acute abdomen
- Any type of malignancy involving the digestive tract in the last 5 years
- Presence of pseudo pancreatic cysts >= 4 cm
- Current excessive intake of alcohol or drug abuse
- Hypersensitivity vs porcine proteins / pancreatin
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Site Reference ID/Investigator# 45389
Bangalore, 560017
Site Reference ID/Investigator# 45396
Bhopal, 462 016
Site Reference ID/Investigator# 45390
Chennai, 600096
Site Reference ID/Investigator# 45391
Hyderabad, 500082
Site Reference ID/Investigator# 45388
Jaipur, 302001
Site Reference ID/Investigator# 54382
Kochi, 682304
Site Reference ID/Investigator# 45387
Kolkata, 700054
Site Reference ID/Investigator# 45383
Mumbai, 400012
Site Reference ID/Investigator# 45382
Pune, 411 004
Site Reference ID/Investigator# 45395
Pune, 411013
Site Reference ID/Investigator# 45393
Trivandrum, 695607
About this study
Official title: A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension
This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.
- Conditions
- Pancreatic Insufficiency
- Being tested
- Pancreatin, Placebo
- Keywords
- Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
- 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.
PancreatinDrug
Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pancreatin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CFA from baseline to the end of double blind treatment
Measured: 7 days after baseline
Secondary outcomes (1)
CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
Measured: 7 days after baseline, and end of open-label period (1 year of open label treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionMay 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Datamap
- Investigators
- Guenter Krause, MD, Study director, Abbott Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705978
- Sponsor's protocol ID
- S245.4.009
- Status last verified
- Aug 2011
- First submitted
- 26 Jun 2008
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension
- ClinicalTrials.gov ID
- NCT00705978
- Acronym / sponsor ID
- S245.4.009
- Conditions
- Pancreatic Insufficiency
- Keywords
- Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Datamap
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Jun 2008 (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.
This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pancreatin |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
- Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
- Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
- Subjects with a pathological stool fat during run in period (> 10g/24 h)
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 cysts >= 4 cm
- Current excessive intake of alcohol or drug abuse
- Hypersensitivity vs porcine proteins / pancreatin
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 |
|---|---|---|
| PancreatinPancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks) | Drug | 1 |
| Placeboplacebo | Drug | 2 |
Primary outcome
Change in CFA from baseline to the end of double blind treatment
Time frame: 7 days after baseline
1 secondary outcome
CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
Time frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
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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.
Guenter Krause, MD study director
Abbott Products
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pancreatin in people with Pancreatic Insufficiency, run by Abbott Products at 11 sites in India.
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 4 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 18 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 11 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in CFA from baseline to the end of double blind treatment (time frame: 7 days after baseline). 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 18 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.