NCT00705978

Brief Summary

This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

11 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

June 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

June 26, 2008

Last Update Submit

August 16, 2011

Conditions

Pancreatic Insufficiency

Keywords

Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Change in CFA from baseline to the end of double blind treatment

    7 days after baseline

Secondary Outcomes (1)

  • CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI

    7 days after baseline, and end of open-label period (1 year of open label treatment)

Study Arms (2)

1

EXPERIMENTAL
Drug: Pancreatin

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PancreatinDRUG

Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)

1
PlaceboDRUG

placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
  • Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
  • Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
  • Subjects with a pathological stool fat during run in period (\> 10g/24 h)

You may not qualify if:

  • Ileus or acute abdomen
  • Any type of malignancy involving the digestive tract in the last 5 years
  • Presence of pseudo pancreatic cysts \>= 4 cm
  • Current excessive intake of alcohol or drug abuse
  • Hypersensitivity vs porcine proteins / pancreatin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Site Reference ID/Investigator# 45389

Bangalore, 560017, India

Location

Site Reference ID/Investigator# 45396

Bhopal, 462 016, India

Location

Site Reference ID/Investigator# 45390

Chennai, 600096, India

Location

Site Reference ID/Investigator# 45391

Hyderabad, 500082, India

Location

Site Reference ID/Investigator# 45388

Jaipur, 302001, India

Location

Site Reference ID/Investigator# 54382

Kochi, 682304, India

Location

Site Reference ID/Investigator# 45387

Kolkata, 700054, India

Location

Site Reference ID/Investigator# 45383

Mumbai, 400012, India

Location

Site Reference ID/Investigator# 45382

Pune, 411 004, India

Location

Site Reference ID/Investigator# 45395

Pune, 411013, India

Location

Site Reference ID/Investigator# 45393

Trivandrum, 695607, India

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancreatin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

HydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

  • Guenter Krause, MD

    Abbott Products

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 27, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

IN(11)