PancreatitisPhase 4NCT00999232
Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
A Phase 4 study testing Erythromycin in people with Pancreatitis, run by Canisius-Wilhelmina Hospital.
Trial summary
The purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Erythromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jul 2007
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years
- Having pancreatitis
- Require jejunal enteral nutrition
Who cannot join
- Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum)
- Pregnancy
- Hypersensibility to erythromycin
- Cardiac arrhythmias with a prolonged QT-time
- Simultaneous usage of drugs impairing peristalsis
About this study
The purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.
- Conditions
- Pancreatitis
- Being tested
- Erythromycin, Placebo
- Keywords
- erythromycin, prokinetics, nasojejunal tubes, Bengmark feeding tube, post-pyloric feeding, pancreatitis, Non-critically ill patients having pancreatitis who require jejunal enteral nutrition
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube
PlaceboDrug
Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Experimental | Not described Receives: Drug: Erythromycin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.
Secondary outcomes (2)
The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.
Adverse events using this self-propelled tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2004
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999232
- Sponsor's protocol ID
- Bengmark_v1
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 22 Jan 2010
- Results posted
- No
Publications
van den Bosch S, Witteman E, Kho Y, Tan AC. Erythromycin to promote bedside placement of a self-propelled nasojejunal feeding tube in non-critically ill patients having pancreatitis: a randomized, double-blind, placebo-controlled study. Nutr Clin Pract. 2011 Apr;26(2):181-5. doi: 10.1177/0884533611399924.
PubMed 21447772
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
- ClinicalTrials.gov ID
- NCT00999232
- Acronym / sponsor ID
- Bengmark_v1
- Conditions
- Pancreatitis
- Keywords
- erythromycin, prokinetics, nasojejunal tubes, Bengmark feeding tube, post-pyloric feeding, pancreatitis, Non-critically ill patients having pancreatitis who require jejunal enteral nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Canisius-Wilhelmina HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jul 2007 (actual)
- First posted
- 21 Oct 2009 (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 purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Experimental | Drug: Erythromycin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-80 years
- Having pancreatitis
- Require jejunal enteral nutrition
Key exclusion criteria (5 listed)
- Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum)
- Pregnancy
- Hypersensibility to erythromycin
- Cardiac arrhythmias with a prolonged QT-time
- Simultaneous usage of drugs impairing peristalsis
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 |
|---|---|---|
| ErythromycinSubjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube | Drug | Erythromycin |
| PlaceboSubjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube | Drug | Placebo |
Primary outcome
The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.
2 secondary outcomes
The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.
Adverse events using this self-propelled tube
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 22 Jan 2010.
- Derived from this study: PubMed 21447772van den Bosch S, Witteman E, Kho Y, Tan AC. Erythromycin to promote bedside placement of a self-propelled nasojejunal feeding tube in non-critically ill patients having pancreatitis: a randomized, double-blind, placebo-controlled study. Nutr Clin Pract. 2011 Apr;26(2):181-5. doi: 10.1177/0884533611399924.
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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 Phase 4 study testing Erythromycin in people with Pancreatitis, run by Canisius-Wilhelmina 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 3 inclusion and 5 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 22 Jan 2010. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999232, which also lists 1 linked publication.
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 22 Jan 2010.