NCT00160186

Brief Summary

The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2003

Typical duration for phase_4

Geographic Reach
4 countries

9 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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

March 31, 2008

Status Verified

March 1, 2008

Enrollment Period

2.4 years

First QC Date

September 9, 2005

Last Update Submit

March 28, 2008

Conditions

Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Baseline-adjusted body mass index (BMI) after 6 months therapy

    6 months

Secondary Outcomes (1)

  • Effect on body composition, on stool fat, on the coefficient of fat absorption, stool weight, quality of life (Qol), clinical symptoms (gastrointestinal), data from the diary, Elastase

    6 months

Study Arms (2)

1

EXPERIMENTAL
Drug: Pancreatin

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PancreatinDRUG

2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 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:

  • Informed consent
  • Males or females
  • Age \>= 18 years
  • Total or subtotal gastrectomy
  • Females having negative pregnancy test or being surgically sterile or 1 year postmenopausal; women of childbearing age must use effective birth control.

You may not qualify if:

  • Diseases or conditions limiting the participation in, or completion of, the study
  • Progressive tumors/metastasis
  • Complications leading to insufficient peroral nutrition
  • Known allergy to pancreatin
  • Known exocrine insufficiency
  • Experimental drug intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Site 9

Odense, Denmark

Location

Site 10

Tampere, Finland

Location

Site 1

Bergen, Norway

Location

Site 2

Fredrikstad, Norway

Location

Site 3

Tromsø, Norway

Location

Site 5

Linköping, Sweden

Location

Site 7

Malmo, Sweden

Location

Site 6

Stockholm, Sweden

Location

Site 8

Stockholm, Sweden

Location

MeSH Terms

Interventions

Pancreatin

Intervention Hierarchy (Ancestors)

HydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

December 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 31, 2008

Record last verified: 2008-03

Locations

SE(4)DK(1)FI(1)NO(3)