NCT02415959

Brief Summary

The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 17, 2016

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

March 19, 2015

Results QC Date

January 20, 2016

Last Update Submit

March 7, 2016

Conditions

Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

Keywords

Exocrine Pancreatic Insufficiency

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

    End of the 6 to 7 days double-blind treatment period

Secondary Outcomes (3)

  • Coefficient of Nitrogen Absorption (CNA)

    End of the 6 to 7 days double-blind treatment period

  • Stool Fat Content

    End of the 6 to 7 days double-blind treatment period

  • Stool Weight

    End of the 6 to 7 days double-blind treatment period

Other Outcomes (1)

  • Treatment Emergent Adverse Events

    From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days

Study Arms (5)

Creon IR low dose

EXPERIMENTAL

Creon IR 300 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)

Drug: Creon IR

Creon IR medium dose

EXPERIMENTAL

Creon IR 1,200 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)

Drug: Creon IR

Creon IR high dose

EXPERIMENTAL

Creon IR 2,400 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)

Drug: Creon IR

Creon IR maximum dose

EXPERIMENTAL

Creon IR 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)

Drug: Creon IR

Creon® (DR/GR)

ACTIVE COMPARATOR

Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)

Drug: Creon® (DR/GR)

Interventions

Creon IRDRUG
Creon IR high doseCreon IR low doseCreon IR maximum doseCreon IR medium dose
Creon® (DR/GR)DRUG
Creon® (DR/GR)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has voluntarily signed and dated the Informed Consent Form (ICF). For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the Independent Ethics Committee (IEC), assent will be given by the subject.
  • Subject is 12 years old or older at the time of consent signature.
  • Subject has a diagnosis of CF previously confirmed by:
  • a sweat chloride test \> or equal to 60 mmol/Ls and/or
  • two CF causing Cystic Fibrosis trans membrane conductance regulator (CFTR) mutations and
  • CF clinical features
  • Subject has a documented clinically confirmed diagnosis of pancreatic exocrine insufficiency.
  • Subject has human fecal elastase \< 100 µg/g stool at screening
  • Subject has PEI that is currently clinically controlled (no clinically overt steatorrhea or diarrhea) under treatment with a commercially available Pancreatic enzyme Replacement Therapy (PERT), on an individually established dose regimen for more than 3 months, with a daily dose not exceeding 10,000 U lipase/kg/day.
  • Females of child-bearing potential and sexually active with men should agree to continue using a medically acceptable method of birth control throughout the study and for 7 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 (e.g., Depo Provera™), an intrauterine device, or an oral contraceptive taken continually within the past three months and which 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:

  • Subject is \< 18 years of age and has a Body Mass Index (BMI) Z-Score below -1.5 (minus 1.5)
  • Subject has a history of any of the following gastrointestinal disorders:
  • pancreatitis within 6 months prior to study entry;
  • fibrosing colonopathy;
  • distal ileal obstruction syndrome (DIOS) within 6 months prior to study entry;
  • celiac disease;
  • gastric bypass or partial/total gastrectomy;
  • Crohn's disease;
  • small bowel surgery (other than minor resection due to meconium ileus without resulting in malabsorption syndrome).
  • Any type of malignancy involving the digestive tract in the last 5 years.
  • Subjects with diabetes mellitus, for which the study specific dietary requirements may not be appropriate.
  • Subject has a history of other endocrine or respiratory (except mild asthma) medical illness non-related to CF, which might limit participation in or completion of the study.
  • Subject has a history of any clinically significant neurological, cardiac, renal, hepatic (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any other uncontrolled medical illness (except cystic fibrosis) which might limit participation in or completion of the study.
  • Subjects requiring concomitant treatment with any medication not allowed by the protocol or is expected to be needed.
  • Subjects requiring Naso-gastric, G-tubes or J-tubes.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Dětská nemocnice FN Brno, Centrum pro cystickou fibrozu

Brno, 61300, Czechia

Location

Klinika nemocí plicních a TBC

Brno, 62500, Czechia

Location

Magyar Imre Kórház

Ajka, 8400, Hungary

Location

Kenézy Gyula Kórház

Debrecen, 4031, Hungary

Location

Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

Location

Tüdőgyógyintézet Törökbálint

Törökbálint, 2045, Hungary

Location

Centrum Medyczne Karpacz S.A.

Karpacz, 58-540, Poland

Location

Wojewódzki Szpital Specjalistyczny Im M Kopernika W Łodzi

Lodz, 93-513, Poland

Location

Janusz Stankiewicz Sanatorium ""Cassia-Villa Medica

Rabka-Zdrój, 34-700, Poland

Location

Podkarpacki Ośrodek Pulmonologii i Alergologii

Rzeszów, 35-612, Poland

Location

ENEL-MED Szpital Centrum

Warsaw, 01-195, Poland

Location

Hospital Vall d ´Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Carlos Haya, Hospital Civil, Secretaria de Endocrinologia

Málaga, 29009, Spain

Location

Hospital Universitario Virgen del Rocío, Hospital de la Mujer

Seville, 41013, Spain

Location

Hospital La Fé Valencia

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Results Point of Contact

Title
Suntje Sander-Struckmeier
Organization
Abbott
suntje.sander@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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 14, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 4, 2016

Results First Posted

February 17, 2016

Record last verified: 2016-03

Locations

ES(6)PL(5)CZ(2)HU(4)