Trial · NCT03924947
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT03924947, Phase 4, Completed, AbbVie; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis. Trials, record NCT03924947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03924947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
- NCT number
- NCT03924947
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 36 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Cystic Fibrosis
- Interventions
- Pancrelipase, Pancrelipase
- First posted
- 2019-04-23
- Last updated
- 2023-09-28
- Other registries' IDs
- eudract:2017-000578-12
- Results first posted
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 Coefficient of Fat Absorption (CFA) | Up to Day 8 of each DB treatment period | CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period. |
| Primary | Part 2 Coefficient of Fat Absorption (CFA) | Up to Day 8 of each DB treatment period | CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period. |
| Secondary | Coefficient of Nitrogen Absorption (CNA) | Up to Day 8 of each DB treatment period | The CNA is calculated as 100\*\[nitrogen intake - nitrogen excretion\]/nitrogen intake. Nitrogen intake was determined from protein content of food consumed on Day 3, 4, 5 of each treatment period. Nitrogen excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period. |
| Secondary | Stool Fat | Up to Day 8 of each DB treatment period | Total amount of fat excreted during the stool collection period. Stool fat was determined from the stool fat in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period. |
| Secondary | Stool Weight | Up to Day 8 of each DB treatment period | Stool weight was determined from the net weight of the stool samples collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1 Coefficient of Fat Absorption (CFA) | Up to Day 8 of each DB treatment period | Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods | percentage of fat intake absorbed | LEAST_SQUARES_MEAN |
| SECONDARY | Coefficient of Nitrogen Absorption (CNA) | Up to Day 8 of each DB treatment period | Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods | percentage of nitrogen absorbed | LEAST_SQUARES_MEAN |
| SECONDARY | Stool Fat | Up to Day 8 of each DB treatment period | Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods | grams | LEAST_SQUARES_MEAN |
| SECONDARY | Stool Weight | Up to Day 8 of each DB treatment period | Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods | grams | LEAST_SQUARES_MEAN |
| PRIMARY | Part 2 Coefficient of Fat Absorption (CFA) | Up to Day 8 of each DB treatment period | Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods | percentage of fat intake absorbed | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 Coefficient of Fat Absorption (CFA) | Part 1 DB Creon | 85.53 | Standard Error 1.898 | percentage of fat intake absorbed | |
| Part 1 Coefficient of Fat Absorption (CFA) | Part 1 DB Creon MP | 84.59 | Standard Error 1.898 | percentage of fat intake absorbed | |
| Coefficient of Nitrogen Absorption (CNA) | Part 1 DB Creon | 85.01 | Standard Error 1.058 | percentage of nitrogen absorbed | |
| Coefficient of Nitrogen Absorption (CNA) | Part 1 DB Creon MP | 85.04 | Standard Error 1.058 | percentage of nitrogen absorbed | |
| Coefficient of Nitrogen Absorption (CNA) | Part 2 DB Creon | 85.67 | Standard Error 1.223 | percentage of nitrogen absorbed | |
| Coefficient of Nitrogen Absorption (CNA) | Part 2 Double-Blind Creon AAPIS | 86.50 | Standard Error 1.223 | percentage of nitrogen absorbed | |
| Stool Fat | Part 1 DB Creon | 44.52 | Standard Error 5.848 | grams | |
| Stool Fat | Part 1 DB Creon MP | 47.88 | Standard Error 5.848 | grams | |
| Stool Fat | Part 2 DB Creon | 37.46 | Standard Error 4.734 | grams | |
| Stool Fat | Part 2 DB Creon AAPIS | 34.19 | Standard Error 4.734 | grams |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Open Label Pre-Randomization | STARTED | Part 1 OL Creon | 26 | |
| Part 1: Open Label Pre-Randomization | STARTED | Part 1 DB Creon MP / Creon | 0 | |
| Part 1: Open Label Pre-Randomization | STARTED | Part 1 DB Creon / Creon MP | 0 | |
| Part 1: Open Label Pre-Randomization | STARTED | Part 2 OL Creon | 0 | |
| Part 1: Open Label Pre-Randomization | STARTED | Part 2 DB Creon AAPIS / Creon | 0 | |
| Part 1: Open Label Pre-Randomization | STARTED | Part 2 DB Creon / Creon AAPIS | 0 | |
| Part 1: Open Label Pre-Randomization | COMPLETED | Part 1 OL Creon | 26 | |
| Part 1: Open Label Pre-Randomization | COMPLETED | Part 1 DB Creon MP / Creon | 0 | |
| Part 1: Open Label Pre-Randomization | COMPLETED | Part 1 DB Creon / Creon MP | 0 | |
| Part 1: Open Label Pre-Randomization | COMPLETED | Part 2 OL Creon | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NAUSEA | Gastrointestinal disorders | Part 1 OL Creon Pre-Randomization | 0 | 31 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Part 1 DB Creon | 1 | 26 | 1 |
| other | NAUSEA | Gastrointestinal disorders | Part 1 DB Creon MP | 0 | 25 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Part 1 OL Creon Post-Randomization | 0 | 26 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Part 2 OL Creon Pre-Randomization | 0 | 27 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Part 2 DB Creon | 2 | 23 | 3 |
| other | NAUSEA | Gastrointestinal disorders | Part 2 DB Creon AAPIS | 1 | 23 | 2 |
| other | NAUSEA | Gastrointestinal disorders | Part 2 OL Creon Post-Randomization | 0 | 23 | 0 |
| other | VOMITING | Gastrointestinal disorders | Part 1 OL Creon Pre-Randomization | 0 | 31 | 0 |
| other | VOMITING | Gastrointestinal disorders | Part 1 DB Creon | 1 | 26 | 1 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 OL Creon Pre-Randomization | 0 | 31 |
| Total, all-cause mortality | Part 1 DB Creon | 0 | 26 |
| Total, all-cause mortality | Part 1 DB Creon MP | 0 | 25 |
| Total, all-cause mortality | Part 1 OL Creon Post-Randomization | 0 | 26 |
| Total, all-cause mortality | Part 2 OL Creon Pre-Randomization | 0 | 27 |
| Total, all-cause mortality | Part 2 DB Creon | 0 | 23 |
| Total, all-cause mortality | Part 2 DB Creon AAPIS | 0 | 23 |
| Total, all-cause mortality | Part 2 OL Creon Post-Randomization | 0 | 23 |
| Total, other adverse events | Part 1 OL Creon Pre-Randomization | 4 | 31 |
| Total, other adverse events | Part 1 DB Creon | 1 | 26 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03924947
GET https://conductscience.org/api/trials/v1/NCT03924947/flow?page=2