Trial Outcomes & Findings for A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI) (NCT NCT03859869)
NCT ID: NCT03859869
Last Updated: 2023-06-05
Results Overview
Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
Baseline (Day 1), Week 1 (Day 8)
Results posted on
2023-06-05
Participant Flow
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Neither the Resected Participants Receiving Low Dose Pancrelipase group nor the Non-Resected Participants Receiving High Dose Pancrelipase group enrolled any participants.
Participant milestones
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.
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|---|---|---|---|
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Overall Study
STARTED
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0
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Baseline characteristics by cohort
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
n=1 Participants
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.
|
Total
n=1 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Customized
Age 21 - 90 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Week 1 (Day 8)Population: Participants who received at least one dose of study drug and who had evaluable stool fat at both Baseline and Week 1 visits
Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.
Outcome measures
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
n=1 Participants
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
|---|---|---|
|
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
|
—
|
3.1 g/24 hours
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1 (Day 8)Population: Participants who received at least one dose of study drug
Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.
Outcome measures
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
n=1 Participants
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
|---|---|---|
|
Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
|
—
|
NA number of stools/day
Not calculable/estimable because stool frequency data for Week 1 is missing
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1 (Day 8)Population: Participants who received at least one dose of study drug
Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.
Outcome measures
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
n=1 Participants
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
|---|---|---|
|
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
|
—
|
-0.29 proportion of days w/ watery consistency
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1 (Day 8)Population: Participants who received at least one dose of study drug
The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.
Outcome measures
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
n=1 Participants
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
|---|---|---|
|
Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
|
—
|
3 units on a scale
|
Adverse Events
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
n=1 participants at risk
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
|
Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase
Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.
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|---|---|---|---|
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Investigations
WHITE BLOOD CELLS DECREASED
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
100.0%
1/1 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
|
General disorders
FATIGUE
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
|
Nervous system disorders
POSTURAL DIZZINESS
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
—
0/0 • All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.
Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER