NCT00776360

Brief Summary

The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2008

Shorter than P25 for early_phase_1

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

October 17, 2008

Last Update Submit

April 6, 2015

Conditions

Postprocedural Delayed Gastric Emptying

Keywords

oxytocingastroparesisdiabeticsThe effect of oxytocin on gastric emptying

Outcome Measures

Primary Outcomes (1)

  • To examine whether oxytocin improves gastric emptying in gastroparesis

    dec 2008-dec 22009

Study Arms (2)

oxytocin, gastric emptying

EXPERIMENTAL

Oxytocin is given to study the gastric emptying rate

Drug: oxytocin

oxytocin

PLACEBO COMPARATOR

sodium chloride is given to study gastric emptying rate

Drug: oxytocin

Interventions

oxytocinDRUG

80mIE/min as continuous infusion for 70 minutes

Also known as: syntocinon
oxytocinoxytocin, gastric emptying

Eligibility Criteria

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

You may qualify if:

  • Gastroparesis in diabetics

You may not qualify if:

  • Treatment with other prokinetics, other severe organic or psychological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroparesis

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Clinical Sciences, Division of Internal Medicine

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 21, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 7, 2015

Record last verified: 2015-04