Trial Outcomes & Findings for A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis (NCT NCT02137382)
NCT ID: NCT02137382
Last Updated: 2016-01-22
Results Overview
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake
COMPLETED
PHASE3
41 participants
5 days
2016-01-22
Participant Flow
50 patients consented, between January and March 2014.
41 of the 50 patients who consented were randomized; the 9 patients who were not randomized were screening failures.
Participant milestones
| Measure |
Sequence: Creon N/Creon®
Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
|
Sequence: Creon®/Creon N
Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
|
|---|---|---|
|
Cross-over Period 1
STARTED
|
20
|
21
|
|
Cross-over Period 1
COMPLETED
|
18
|
21
|
|
Cross-over Period 1
NOT COMPLETED
|
2
|
0
|
|
Wash Out
STARTED
|
18
|
21
|
|
Wash Out
COMPLETED
|
18
|
21
|
|
Wash Out
NOT COMPLETED
|
0
|
0
|
|
Cross-over Period 2
STARTED
|
18
|
21
|
|
Cross-over Period 2
COMPLETED
|
18
|
21
|
|
Cross-over Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Sequence Creon N/Creon® or Creon®/Creon N
n=41 Participants
Participants who were randomized to receive either Creon N or Creon.
|
|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Per protocol
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Coefficient of Fat Absorption (CFA)
|
88.1 percentage of fat intake
Standard Deviation 9.23
|
89.5 percentage of fat intake
Standard Deviation 6.79
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Per protocol
CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 \[nitrogen intake - nitrogen excretion\] / nitrogen intake)
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Coefficient of Nitrogen Absorption (CNA).
|
87.7 percentage of nitrogen intake
Standard Deviation 5.47
|
87.8 percentage of nitrogen intake
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Per protocol
Total amount of fat excreted during the stool collection period in grams.
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Total Fat Excretion
|
48.1 Grams
Standard Deviation 43.28
|
42.3 Grams
Standard Deviation 27.05
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Per protocol
Stool frequency is the average of the daily number of stools recorded during the treatment period
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Stool Frequency
|
1.57 number of stools per day
Standard Deviation 0.6
|
1.49 number of stools per day
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Per protocol
The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\*(number of days with no flatulence/number of days recorded in diary).
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Percentage of Days With no Flatulence
|
51.6 percentage of days
Standard Deviation 46.65
|
57.5 percentage of days
Standard Deviation 43.31
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Per protocol
The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\*(number of days with no abdominal pain/ number of days recorded in diary).
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Percentage of Days With no Abdominal Pain
|
86.8 percentage of days
Standard Deviation 22.91
|
89.3 percentage of days
Standard Deviation 19.67
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Per protocol
The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\*(number of days with formed/normal stools/ number of days recorded in diary).
Outcome measures
| Measure |
Creon®
n=38 Participants
Creon®: active comparator
|
Creon N
n=38 Participants
Creon N: experimental drug
|
|---|---|---|
|
Percentage of Days With Formed/Normal Stools
|
79.8 percentage of days
Standard Deviation 21.21
|
73.6 percentage of days
Standard Deviation 29.50
|
Adverse Events
Creon®
Creon N
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Creon®
n=39 participants at risk
Creon®: active comparator
|
Creon N
n=41 participants at risk
Creon N: experimental drug
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
7.7%
3/39 • Number of events 3
|
0.00%
0/41
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Number of events 2
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Gastro intestinal hyper motility
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Steatorrhea
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
viral rhinitis
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Investigations
Gastric pH decreased
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place