Trial Outcomes & Findings for Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency (NCT NCT01747330)

Results Overview

change from baseline at day 84

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

3 months

Results posted on

2014-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Creon Micro, Minimicrospheres Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of pancreatin \<2500 lipase u/kg/feed or \<4000 lipase u/g fat/intake or \<10000 lipase u/kg/day given orally are used
Age, Categorical <=18 years	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	1.7 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment Russian Federation	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

change from baseline at day 84

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Body Weight	0.75 kg Standard Deviation 0.61

PRIMARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

change from baseline at day 84

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Height	0.026 m Standard Deviation 0.020

PRIMARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

Average daily stool frequency during treatment period: Number of bowel movements per day

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Stool Frequency	2.1 Bowel movements per day Standard Deviation 0.8

PRIMARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Stool Consistency	55.4 % of days with normal stool consistency Standard Deviation 26.4

PRIMARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Subject's Acceptance of Treatment very good	37.5 percentage of participants
Subject's Acceptance of Treatment good	52.5 percentage of participants
Subject's Acceptance of Treatment moderate	10.0 percentage of participants
Subject's Acceptance of Treatment unsatisfactory	0 percentage of participants

SECONDARY outcome

Timeframe: 4 months

Population: Full Analysis subject sample

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Number of Subjects With Adverse Events	16 participants

SECONDARY outcome

Timeframe: 3 months

Change from Baseline at Day 84

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Pulse	-3.1 bpm Standard Deviation 9.4

SECONDARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Number of Participants With Findings During Physical Examination	12 participants

SECONDARY outcome

Timeframe: 3 months

Population: Full Analysis subject sample

(hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)

Outcome measures

Outcome measures
Measure	Creon Micro, Minimicrospheres n=40 Participants Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Number of Participants With Clinical Relevant Safety Laboratory Values	0 participants

Adverse Events

Creon Micro, Minimicrospheres

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Creon Micro, Minimicrospheres n=40 participants at risk Pancreatin: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used
Infections and infestations infections NEC	15.0% 6/40 • Number of events 8
Infections and infestations upper respiratory tract infections	7.5% 3/40 • Number of events 4
Gastrointestinal disorders gastrointestinal spastic and hypermotility disorders	7.5% 3/40 • Number of events 3

Additional Information

Associate Director Clinical Services

Abbott

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60