Postprocedural Delayed Gastric EmptyingEarly Phase 1NCT00776360
The Effect of Oxytocin on the Gastric Emptying
A Early Phase 1 study testing oxytocin in people with Postprocedural Delayed Gastric Emptying, run by Skane University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postprocedural Delayed Gastric Emptying
- What is being tested?
- oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastroparesis in diabetics
Who cannot join
- Treatment with other prokinetics, other severe organic or psychological diseases
About this study
Official title: The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis
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.
Read the detailed description
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.The gastric emptying is estimade by sitntigraphy during 70 minutes, and performed twicw. Once with saline and once with oxytocin.
- Conditions
- Postprocedural Delayed Gastric Emptying
- Being tested
- oxytocin
- Keywords
- oxytocin, gastroparesis, diabetics, The effect of oxytocin on gastric emptying
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Also called syntocinon
80mIE/min as continuous infusion for 70 minutes
oxytocinDrug
Also called syntocinon
80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| oxytocin, gastric emptying | Experimental | Oxytocin is given to study the gastric emptying rate Receives: Drug: oxytocin |
| oxytocin | Placebo comparator | sodium chloride is given to study gastric emptying rate Receives: Drug: oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine whether oxytocin improves gastric emptying in gastroparesis
Measured: dec 2008-dec 22009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprocedural Delayed Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bodil Ohlsson, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776360
- Sponsor's protocol ID
- 29/2008
- Status last verified
- Apr 2015
- First submitted
- 17 Oct 2008
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis
- ClinicalTrials.gov ID
- NCT00776360
- Acronym / sponsor ID
- 29/2008
- Conditions
- Postprocedural Delayed Gastric Emptying
- Keywords
- oxytocin, gastroparesis, diabetics, The effect of oxytocin on gastric emptying
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.The gastric emptying is estimade by sitntigraphy during 70 minutes, and performed twicw. Once with saline and once with oxytocin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin, gastric emptying | Experimental | Drug: oxytocinOxytocin is given to study the gastric emptying rate |
| oxytocin | Placebo comparator | Drug: oxytocinsodium chloride is given to study gastric emptying rate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastroparesis in diabetics
Key exclusion criteria (1 listed)
- Treatment with other prokinetics, other severe organic or psychological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocinAlso: syntocinon80mIE/min as continuous infusion for 70 minutes | Drug | oxytocin, oxytocin, gastric emptying |
| oxytocinAlso: syntocinon80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy | Drug | oxytocin, oxytocin, gastric emptying |
Primary outcome
To examine whether oxytocin improves gastric emptying in gastroparesis
Time frame: dec 2008-dec 22009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing oxytocin in people with Postprocedural Delayed Gastric Emptying, run by Skane University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine whether oxytocin improves gastric emptying in gastroparesis (time frame: dec 2008-dec 22009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.