Trial · NCT02415959
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT02415959, Phase 2, Completed, Abbott; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis. Trials, record NCT02415959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02415959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- NCT number
- NCT02415959
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
- Interventions
- Creon IR, Creon® (DR/GR)
- First posted
- 2015-04-14
- Last updated
- 2016-04-04
- Other registries' IDs
- eudract:2014-004519-35
- Results first posted
- 2016-02-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Coefficient of Fat Absorption (CFA) | End of the 6 to 7 days double-blind treatment period | CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake |
| Secondary | Coefficient of Nitrogen Absorption (CNA) | End of the 6 to 7 days double-blind treatment period | CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 \[nitrogen intake - nitrogen excretion\] / nitrogen intake) |
| Secondary | Stool Fat Content | End of the 6 to 7 days double-blind treatment period | Total amount of fat excreted during the stool collection period in grams. |
| Secondary | Stool Weight | End of the 6 to 7 days double-blind treatment period | Total amount of stool weight during the collection period in grams |
| Other | Treatment Emergent Adverse Events | From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days | Treatment emergent adverse events will be summarized per treatment group |
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 | Coefficient of Fat Absorption (CFA) | End of the 6 to 7 days double-blind treatment period | Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory). | percentage of fat intake | MEAN |
| SECONDARY | Coefficient of Nitrogen Absorption (CNA) | End of the 6 to 7 days double-blind treatment period | Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory). | percentage of nitrogen intake | MEAN |
| SECONDARY | Stool Fat Content | End of the 6 to 7 days double-blind treatment period | Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory). | gram per 72 hours | MEAN |
| SECONDARY | Stool Weight | End of the 6 to 7 days double-blind treatment period | Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory). | gram per 72 hours | MEAN |
| OTHER_PRE_SPECIFIED | Treatment Emergent Adverse Events | From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Coefficient of Fat Absorption (CFA) | Creon IR Low Dose | 71.0 | Standard Deviation 12.4 | percentage of fat intake | |
| Coefficient of Fat Absorption (CFA) | Creon IR Medium Dose | 70.9 | Standard Deviation 13.9 | percentage of fat intake | |
| Coefficient of Fat Absorption (CFA) | Creon IR High Dose | 71.8 | Standard Deviation 15.2 | percentage of fat intake | |
| Coefficient of Fat Absorption (CFA) | Creon IR Maximum Dose | 75.9 | Standard Deviation 9.2 | percentage of fat intake | |
| Coefficient of Fat Absorption (CFA) | Creon® (DR/GR) | 92.3 | Standard Deviation 3.7 | percentage of fat intake | |
| Coefficient of Nitrogen Absorption (CNA) | Creon IR Low Dose | 71.0 | Standard Deviation 10.0 | percentage of nitrogen intake | |
| Coefficient of Nitrogen Absorption (CNA) | Creon IR Medium Dose | 73.2 | Standard Deviation 6.4 | percentage of nitrogen intake | |
| Coefficient of Nitrogen Absorption (CNA) | Creon IR High Dose | 76.2 | Standard Deviation 8.1 | percentage of nitrogen intake | |
| Coefficient of Nitrogen Absorption (CNA) | Creon IR Maximum Dose | 79.9 | Standard Deviation 7.3 | percentage of nitrogen intake | |
| Coefficient of Nitrogen Absorption (CNA) | Creon® (DR/GR) | 84.8 | Standard Deviation 4.3 | percentage of nitrogen intake |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Creon IR Low Dose | 14 | |
| Overall Study | STARTED | Creon IR Medium Dose | 14 | |
| Overall Study | STARTED | Creon IR High Dose | 14 | |
| Overall Study | STARTED | Creon IR Maximum Dose | 14 | |
| Overall Study | STARTED | Creon® (DR/GR) | 14 | |
| Overall Study | COMPLETED | Creon IR Low Dose | 14 | |
| Overall Study | COMPLETED | Creon IR Medium Dose | 13 | |
| Overall Study | COMPLETED | Creon IR High Dose | 14 | |
| Overall Study | COMPLETED | Creon IR Maximum Dose | 13 | |
| Overall Study | COMPLETED | Creon® (DR/GR) | 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events35
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 | Abdominal pain | Gastrointestinal disorders | Creon IR Low Dose | 6 | 14 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Creon IR Medium Dose | 8 | 14 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Creon IR High Dose | 6 | 14 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Creon IR Maximum Dose | 4 | 14 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Creon® (DR/GR) | 2 | 14 | 2 |
| other | Flatulence | Gastrointestinal disorders | Creon IR Low Dose | 2 | 14 | 2 |
| other | Flatulence | Gastrointestinal disorders | Creon IR Medium Dose | 2 | 14 | 2 |
| other | Flatulence | Gastrointestinal disorders | Creon IR High Dose | 6 | 14 | 6 |
| other | Flatulence | Gastrointestinal disorders | Creon IR Maximum Dose | 3 | 14 | 3 |
| other | Flatulence | Gastrointestinal disorders | Creon® (DR/GR) | 2 | 14 | 2 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Creon IR Low Dose | ||
| Total, all-cause mortality | Creon IR Medium Dose | ||
| Total, all-cause mortality | Creon IR High Dose | ||
| Total, all-cause mortality | Creon IR Maximum Dose | ||
| Total, all-cause mortality | Creon® (DR/GR) | ||
| Total, other adverse events | Creon IR Low Dose | 10 | 14 |
| Total, other adverse events | Creon IR Medium Dose | 9 | 14 |
| Total, other adverse events | Creon IR High Dose | 7 | 14 |
| Total, other adverse events | Creon IR Maximum Dose | 9 | 14 |
| Total, other adverse events | Creon® (DR/GR) | 7 | 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT02415959
GET https://conductscience.org/api/trials/v1/NCT02415959/results?page=2