Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00501657




Registration number
NCT00501657
Ethics application status
Date submitted
13/07/2007
Date registered
16/07/2007
Date last updated
29/10/2015

Titles & IDs
Public title
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Scientific title
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Secondary ID [1] 0 0
061025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitagliptin
Treatment: Drugs - Placebo

Experimental: Sitagliptin (100mg) - Active drug (sitagliptin)

Placebo comparator: Placebo (sugar pill) - Inactive drug (placebo)


Treatment: Drugs: Sitagliptin
100mg mane for 2 days

Treatment: Drugs: Placebo
100mg mane for 2 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gastric emptying rate
Timepoint [1] 0 0
4 hours per study
Secondary outcome [1] 0 0
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite
Timepoint [1] 0 0
4 hours per study

Eligibility
Key inclusion criteria
* Male or female (females must be using an appropriate contraceptive method)
* 18 - 45 years
* Body mass index (BMI) 19 - 25 kg/m2.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms
* Subjects taking medication known to influence gastrointestinal function
* Alcohol intake > 20 g per day
* Smoking > 10 cigarettes per day
* Pregnant and/or lactating females
* Calculated creatinine clearance < 60 ml/min
* Exposure to ionising radiation for research purposes in the previous 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Discipline of Medicine, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Adelaide Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karen L Jones, PhD
Address 0 0
University of Adelaide, Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00501657