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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00789841
Other study ID # M-20080121
Secondary ID
Status Completed
Phase N/A
First received November 11, 2008
Last updated October 25, 2010
Start date September 2008
Est. completion date May 2010

Study information

Verified date October 2010
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).

Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- NET confirmed by histology

- Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.

- Newly referred patients without previous somatostatin analogue treatment or

- NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.

Exclusion Criteria:

- Subjects unable to understand the information

- Severe diabetes with late complications or known metabolic disorder

- Inflammatory bowel disease

- Known clinically significant stenosis of the bowel

- Bile acid malabsorption due to intestinal surgery

- Small bowl bacterial overgrowth

Study Design

N/A


Intervention

Device:
Magnetic Tracking System (MTS) and radio-opaque markers
MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles ?, f) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.

Locations

Country Name City State
Denmark Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A Aarhus

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Novartis, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastrointestinal transit time in NET patients End of the study No
Secondary Gastric emptying in NET patients End of the study No
Secondary Small intestinal transit time End of the study No
Secondary Small intestinal velocity End of the study No
Secondary Changes in carcinoid symptoms and biomarkers End of the study No
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