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

NCT02137382 | Completed Phase 3 Results

• 2 other identifiers: PANC30042013-002819-10
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 7

Brief Summary

maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis

Conditions

Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Keywords

maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Coefficient of Fat Absorption (CFA)

  CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake

  5 days

Secondary Outcomes (6)

• Coefficient of Nitrogen Absorption (CNA).

  5 days

• Total Fat Excretion

  5 days

• Stool Frequency

  5 days

• Percentage of Days With no Flatulence

  5 days

• Percentage of Days With no Abdominal Pain

  5 days

Study Arms (2)

Creon N, then Creon®

EXPERIMENTAL

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.

Drug: Creon®

Creon® , then Creon N

EXPERIMENTAL

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.

Drug: Creon N

Interventions

Creon® DRUG

active comparator

Creon N, then Creon®

Creon N DRUG

experimental drug

Creon® , then Creon N

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
• Age ≥ 12 years
• Subjects who are able to swallow capsules with each meal and snacks
• Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis
• Diagnosis of pancreatic exocrine insufficiency proven by:
• Coefficient of fat absorption (CFA) \< 70% without supplementation
• or Human fecal elastase \< 50 μg/g stool
• Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
• Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
• Stable body weight defined as no more than a 5% decline within 3 months of enrolment
• Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.

You may not qualify if:

• Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study
• History of acute abdomen
• History of fibrosing colonopathy
• History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
• Solid organ transplant or surgery affecting the large bowel other than appendectomy
• Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy)
• Pregnancy or lactation
• Any type of malignancy involving the digestive tract in the last 5 years
• Celiac disease or Crohn's disease
• Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules
• Suspected non-compliance or non-cooperation
• Intake of experimental drugs within 30 days prior to study start
• Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study
• Diagnosis of human immunodeficiency virus in medical history.

Sponsors & Collaborators

• Abbott: lead

Study Sites (7)

Research facility ID ORG-000826

Budapest, 1122, Hungary

Location

Research facility ID ORG-000816

Debrecen, 4031, Hungary

Location

Research facility ID ORG-000827

Kaposvár, 7400, Hungary

Location

Research facility ID ORG-000825

Törökbálint, 2045, Hungary

Location

Research facility ID ORG-000829

Barcelona, 8035, Spain

Location

Research facility ID ORG-000828

Seville, 41013, Spain

Location

Research facility ID ORG-000815

Valencia, 46026, Spain

Location

Related Publications (1)

• Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.

  PMID: 32761612 DERIVED

MeSH Terms

Interventions

Pancrelipase

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Results Point of Contact

• Title: Suntje Sander - Struckmeier
• Organization: Abbott

suntje.sander-struckmeier@abbott.com

+49 (0) 511 6750 3254

Study Officials

• Suntje Sander-Struckmeier, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: May 13, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 22, 2016
• Results First Posted: November 27, 2015

Record last verified: 2016-01

Locations

HU (4); ES (3)