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

Pancreatic Exocrine Insufficiency Clinical Trial

Official title:

An Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747330
• Other study ID #: M13-277
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2012
• Last updated: June 13, 2014
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

Description:

A prospective open-label, multi-center study evaluating safety and tolerability of Creon Micro in pediatric subjects from at least one month to less than four years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis (CF). Referring to the European Medicines Agency (EMEA) pediatric age criteria for the purpose of the study, subjects are categorized as infants and toddlers (< 2 years) and children, (2 years to < 4 years). In total, 40 subjects will be enrolled (20 subjects in each age subgroup). Subjects receive their prescribed pancreatic enzyme supplementation at the individual dose until start of treatment with Creon Micro, if the subjects were on pancreatic enzyme supplementation before start of the study. Subjects will be treated with Creon Micro during the study. The treatment duration is 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Years

Eligibility

Inclusion Criteria:

• Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms

Exclusion Criteria:

• Ileus or acute abdomen

• history of fibrosing colonopathy

• history of distal ileal obstruction without surgery

• solid organ transplant or surgery affecting the large bowel, other than appendectomy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Exocrine Insufficiency

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Russian Federation	Site Reference ID/Investigator# 80716	Barnaul
Russian Federation	Site Reference ID/Investigator# 80693	Moscow
Russian Federation	Site Reference ID/Investigator# 80698	Novosibirsk
Russian Federation	Site Reference ID/Investigator# 80713	Novosibirsk
Russian Federation	Site Reference ID/Investigator# 80715	Orenburg
Russian Federation	Site Reference ID/Investigator# 80694	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 80714	Tomsk
Russian Federation	Site Reference ID/Investigator# 80697	Voronezh
Russian Federation	Site Reference ID/Investigator# 80696	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Products

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	change from baseline at day 84	3 months	No
Primary	Height	change from baseline at day 84	3 months	No
Primary	Stool Frequency	Average daily stool frequency during treatment period: Number of bowel movements per day	3 months	No
Primary	Stool Consistency	Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery	3 months	No
Primary	Subject's Acceptance of Treatment	Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.	3 months	No
Secondary	Number of Subjects With Adverse Events		4 months	Yes
Secondary	Pulse	Change from Baseline at Day 84	3 months	Yes
Secondary	Number of Participants With Findings During Physical Examination	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.	3 months	Yes
Secondary	Number of Participants With Clinical Relevant Safety Laboratory Values	(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)	3 months	Yes