Trial Outcomes & Findings for PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer (NCT NCT02985801)
NCT ID: NCT02985801
Last Updated: 2021-03-15
Results Overview
Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
TERMINATED
PHASE1/PHASE2
16 participants
Baseline, 4 weeks, 10 weeks
2021-03-15
Participant Flow
Participant milestones
| Measure |
Placebo First, Then Pancrelipase
Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
Placebo Oral Capsule: Placebo Oral Capsule
|
Pancrelipase First, Then Placebo
Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
Placebo Oral Capsule: Placebo Oral Capsule
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Placebo First, Then Pancrelipase
n=8 Participants
Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
Placebo Oral Capsule: Placebo Oral Capsule
|
Pancrelipase First, Then Placebo
n=8 Participants
Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).
Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
Placebo Oral Capsule: Placebo Oral Capsule
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
65.2 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 10 weeksPopulation: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 10 weeksPopulation: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Pancrelipase
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place