GastroparesisPhase 2NCT01117376
Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients
A Phase 2 study testing Erythromycin and Methylnaltrexone in people with Gastroparesis, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Erythromycin and Methylnaltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIran
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in intensive care unit in a university affiliated hospital
- Receiving continuous enteral feeding through a nasogastric tube
- Gastric residual volume more than 250 ml checked by aspiration technique
Who cannot join
- Receiving the study drugs or metoclopramide within 24 hours of inclusion
- Known allergy to interventional drugs or acetaminophen
- Gastrointestinal bleeding or surgery on GI system within 24 hours of inclusion
- Crohn's disease
- GI perforation or obstruction
- Short bowel syndrome
Show all 19Show fewer
- Liver failure or 2 of the followings:
- Transaminase enzymes more than 3 times normal
- Prothrombin time more than 2 times normal
- Total bilirubin more than 3 times normal
- Patients on hemodialysis or CRRT
- Hemodynamically unstable patients including:
- Mean arterial pressure less than 65 mmHg
- Infusion of inotropes and vasopressors
- Uncorrected acute blood loss; hemoglobin concentration less than 6.5 mg%.
- Documented or suspected pregnancy
- Obesity; actual body weight more than 1.5 times ideal body weight
- Myasthenia Gravis.
- Opioid drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding
42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group.Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug.The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.
- Conditions
- Gastroparesis
- Being tested
- Erythromycin, Methylnaltrexone
- Keywords
- Gastroparesis, Erythromycin, Methylnaltrexone, ICU
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Erythromycin 250 mg intravenous Q6h for 4 doses
MethylnaltrexoneDrug
Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Active comparator | 21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique. Receives: Drug: Erythromycin |
| Methylnaltrexone | Active comparator | 21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique. Receives: Drug: Methylnaltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
to measure gastric emptying time within 8 hours after administration of either 4 doses of 250 mg intravenous erythromycin Q6h or 2 doses of methylnaltrexone 12 mg subcutaneous Q12h with acetaminophen absorption test method
Measured: within 8 hours after drug administration
Secondary outcomes (1)
Tolerance to enteral feeding
Tolerance to enteral feeding administered via nasogastric tube within 24 hours after administration of either erithromycin 250 mg intravenous Q6h or methylnaltrexone 12 mg subcutaneous Q12h.Gastric residual volume will be measured Q4h by aspiration method and if less than 250 ml would be considered as tolerance to enteral feeding.
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117376
- Sponsor's protocol ID
- CT-88-01-36-1601
- Status last verified
- May 2010
- First submitted
- 30 Apr 2010
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding
- ClinicalTrials.gov ID
- NCT01117376
- Acronym / sponsor ID
- CT-88-01-36-1601
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Erythromycin, Methylnaltrexone, ICU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 5 May 2010 (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.
42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group.Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug.The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Active comparator | Drug: Erythromycin21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique. |
| Methylnaltrexone | Active comparator | Drug: Methylnaltrexone21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted in intensive care unit in a university affiliated hospital
- Receiving continuous enteral feeding through a nasogastric tube
- Gastric residual volume more than 250 ml checked by aspiration technique
Key exclusion criteria (19 listed)
- Receiving the study drugs or metoclopramide within 24 hours of inclusion
- Known allergy to interventional drugs or acetaminophen
- Gastrointestinal bleeding or surgery on GI system within 24 hours of inclusion
- Crohn's disease
- GI perforation or obstruction
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 |
|---|---|---|
| ErythromycinErythromycin 250 mg intravenous Q6h for 4 doses | Drug | Erythromycin |
| MethylnaltrexoneMethylnaltrexone 12 mg subcutaneous Q12h for 2 doses | Drug | Methylnaltrexone |
Primary outcome
Gastric emptying time
Time frame: within 8 hours after drug administration
to measure gastric emptying time within 8 hours after administration of either 4 doses of 250 mg intravenous erythromycin Q6h or 2 doses of methylnaltrexone 12 mg subcutaneous Q12h with acetaminophen absorption test method
1 secondary outcome
Tolerance to enteral feeding
Time frame: 24 hours after intervention
Results and safety
The study was stopped early (reason given: The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erythromycin and Methylnaltrexone in people with Gastroparesis, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 19 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: stopped early, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region). Results are not available in the source record.
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?
Gastric emptying time (time frame: within 8 hours after drug administration). 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 31 Mar 2011.