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Control of Steatorrhea in Patients With Cystic Fibrosis and Pancreatic Insufficiency

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Axcan Pharma.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT01327703
First received: March 28, 2011
Last updated: October 31, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to assess the efficacy of Panzytrat™ 25 000 compared to Kreon 25 000 in the control of steatorrhea in cystic fibrosis subjects with exocrine pancreatic insufficiency.


Condition Intervention Phase
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
 Drug: Pancreatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT™ 25 000 to KREON 25 000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • Coefficient of Fat Absorption [ Time Frame: During 72 hours after 14 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool frequency [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
  • Stool weight [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
    Total stool weight and mean weight per stool sample will be assessed

  • Frequency of subject's abdominal symptoms [ Time Frame: During both study treatments (28 to 34 days) ] [ Designated as safety issue: No ]
    Abdominal pain and excessive flatulence/gas production will be assessed as abdominal symptoms.

  • Presence of abdominal distension [ Time Frame: Visits 1, 3 and 4 ] [ Designated as safety issue: No ]
  • Role of acid suppression therapy on Coefficient of Fat Absorption [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
    Each subject will be categorized as an ''acid suppression therapy user'' or a ''non-user''. For both sub-categories (use and no use of acid suppresion therapy), the CFA% measured with the two study drugs will be assessed to see if the use of acid suppresion therapy tends to affect or not the CFA%.

  • Nutritional status of subjects [ Time Frame: Visits 1, 3 and 4 ] [ Designated as safety issue: Yes ]
    The nutritional status of subjects will be briefly described at Visit 1 (baseline) with parameters such as body weight and BMI, as well as blood levels of hemoglobin, hematocrit, transferrin, albumin, electrolytes, vitamins A, D and E. Except for vitamins A, D and E, the other blood level parameters will be compared to baseline at Visit 4 and weight and BMI will be compared to baseline at Visits 3 and 4.

  • Number of adverse events reported by the subjects or found during physical examination or blood and urine tests [ Time Frame: From signature of ICF (Visit 1) to completion of the study (scheduled 7-10 days after Visit 4) or until discontinuation of the study ] [ Designated as safety issue: Yes ]
  • Severity of subject's abdominal symptoms [ Time Frame: During both study treatments (28 to 34 days) ] [ Designated as safety issue: No ]
    The severity of abdominal symptoms reported by the subject, respectively abdominal pain and excessive flatulence/gas production will be assessed.

  • Nature of adverse events reported by the subjects or found during physical examination or blood and urine tests [ Time Frame: From signature of ICF (Visit 1) to completion of the study (scheduled 7-10 days after Visit 4) or until discontinuation of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 68
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panzytrat™ 25000 Drug: Pancreatin
Capsule with gastro-resistant microtablets containing 25,000 Ph. Eur. unit of lipase,at least 15,000 Ph. Eur. unit of amylase and at least 800 Ph. Eur. unit of protease
Other Names:
  • Pancreatic enzyme supplement
  • Pancreatic enzyme products
  • Pancreatic enzyme replacement therapy
Active Comparator: Kreon 25000 Drug: Pancreatin
Capsule with gastro-resistant microtablets containing 25,000 Ph. Eur. unit of lipase,at least 15,000 Ph. Eur. unit of amylase and at least 800 Ph. Eur. unit of protease
Other Names:
  • Pancreatic enzyme supplement
  • Pancreatic enzyme products
  • Pancreatic enzyme replacement therapy
Drug: Pancreatin
Capsule with enteric coated pellets containing 25,000 Ph. Eur. unit of lipase,at least 18,000 Ph. Eur. unit of amylase and at least 1000 Ph. Eur. unit of protease
Other Names:
  • Pancreatic enzyme supplement
  • Pancreatic enzyme products
  • Pancreatic enzyme replacement therapy

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form by the subject
  • Clinical diagnosis of cystic fibrosis
  • Severe Pancreatic insufficiency confirmed by Fecal Elastase-1 (ELISA)
  • Male or female subject aged 7 years or older
  • Current treatment with stable dose of Panzytrat™ 25 000 or Kreon 25 000
  • Women of childbearing potential have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study

Exclusion Criteria:

  • Known hypersensitivity to Panzytrat™ or Kreon, or to any porcine protein
  • Recent treatment with oral or intravenous antibiotics, not completed at least 14 days prior to randomization
  • History of significant bowel resection that could impair fat absorption
  • Presence of any condition known to increase fecal fat loss
  • Presence of any significant gastrointestinal dysmotility disorders
  • Subject with chronic abdominal pain or severe abdominal pain at study entry
  • Use of enteral tube feeding over day and night
  • History or presence of clinically significant portal hypertension
  • Complete Distal Intestinal Obstruction Syndrome (DIOS) in the past six (6) months, or two (2) or more episodes of DIOS in the past year
  • Subject with poorly controlled diabetes as per the investigator's opinion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327703

Contacts
Contact: Marie-Andrée Nadeau 450-467-2600 ext 2464 manadeau@aptalispharma.com
Contact: Roxane Aubray 450-467-2328 raubray@aptalispharma.com

Locations
Germany
Klinikum-Bochum Not yet recruiting
Bochum, Germany
Principal Investigator: Manfred Ballmann, MD            
Universitätsklinikum Carl Gustav Carus Not yet recruiting
Dresden, Germany
Principal Investigator: Jutta Hammermann, MD            
Universitaetsklinikum Erlangen Not yet recruiting
Erlangen, Germany
Principal Investigator: Theodor Zimmermann, MD            
Jena University Hospital, Universitaetsklinikum Jena Recruiting
Jena, Germany
Principal Investigator: Jochen Mainz, MD            
Klinikum der Universitat Munchen Medizinische Klinik-Innenstadt Recruiting
München, Germany
Principal Investigator: Rainald Fischer, MD            
University Children's Clinic Tubingen Recruiting
Tubingen, Germany
Principal Investigator: Joachim Riethmueller, MD            
Poland
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem Poradnia Leczenia Mukowiscydozy Recruiting
Gdansk, Poland
Principal Investigator: Ewa Sapiejka, MD            
Wojewodzki Specjalistityczny Szpital Dziect Im Sw Ludwika Not yet recruiting
Krakow, Poland
Principal Investigator: Zuzanna Kurtyka, MD            
Dziecięcy Szpital Kliniczny im. Prof. Antoniego Gębali Recruiting
Lublin, Poland
Principal Investigator: Grazyna Gornicka, MD            
Szpital Kliniczny im Karola Jonschera Recruiting
Poznan, Poland
Principal Investigator: Jaroslaw Walkowiak, MD            
NZOZ Sanatorium Cassia Villa Medica Recruiting
Rabka Zdrój, Poland
Principal Investigator: Enryk Mazurek, MD            
NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii Recruiting
Rzeszow, Poland
Principal Investigator: Marta Rachel, MD            
Children's Health Memorial Institute Not yet recruiting
Warszawa, Poland
Principal Investigator: Marek Woynarowski, MD            
Sponsors and Collaborators
Axcan Pharma
Investigators
Principal Investigator: Martin Stern, Professor University Children's Clinic Tubingen, Grmany
Principal Investigator: Jaroslaw Walkowiak, Professor Szpital Kliniczny im Karola Jonschera, Poland
  More Information

No publications provided

Responsible Party: Josée Grondin, Axcan Pharma Inc.
ClinicalTrials.gov Identifier: NCT01327703     History of Changes
Other Study ID Numbers: MA-PA25CF10-01, 2010-019267-11
Study First Received: March 28, 2011
Last Updated: October 31, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Axcan Pharma:
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Steatorrhea
Malabsorption
Malnutrition

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Exocrine Pancreatic Insufficiency
Steatorrhea
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
 Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013