Tube FeedingPhase 3NCT01360372
Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates
A Phase 3 study testing Methylnaltrexone and Saline injection in people with Tube Feeding, run by Drexel University at 2 sites in United States.
Trial summary
It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tube Feeding
- What is being tested?
- Methylnaltrexone and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to May 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inadequate tube feeding rate of greater than equal to 40% below goal rate.
- Prescribed opiate therapy for pain or sedation, stable dose for minimum 48 hours
- Stable dose or no dose laxative for minimum 72 hours
Who cannot join
- Unstable Hemodynamics (eg. vasopressor medication)
- Pregnancy
- End stage Renal Disease on Dialysis
- Plan to wean opiates in next 48 hours
- Known or suspected mechanical gastrointestinal obstruction
- Initial expired hydrogen breath level greater than 20
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Cancer Treatment Center of America
Philadelphia, Pennsylvania, 19124
About this study
Official title: The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.
Read the detailed description
Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.
- Conditions
- Tube Feeding
- Being tested
- Methylnaltrexone, Saline injection
- Keywords
- Hydrogen breath test value and gastric residual volume measurements, Tube feeding tolerance while taking a stable dose of opiate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylnaltrexoneDrug
Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight
Saline injectionDrug
Saline 0.4 to 0.8 ml injection
| Study group | Role | What they receive |
|---|---|---|
| Methylnaltrexone | Active comparator | Not described Receives: Drug: Methylnaltrexone |
| saline placebo injection | Placebo comparator | Not described Receives: Drug: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen breath test measure of bowel transit
On day 1 Hydrogen Breath Test (HBT) measures will occur 30 minutes before test meal, immediately after test meal every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. On day 2 Hydrogen Breath test measures will occur 30 minutes before test meal, immediately after test meal and every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed.
Measured: 2 days
Secondary outcomes (1)
Gastric residual volume measurement
Gastric residual volumes will be measured at baseline study entry and then every 4 hours throughout the study until 24 hours post study drug administration.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: No eligible subjects identified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tube FeedingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Michael Sherman, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360372
- Sponsor's protocol ID
- Drexel18538
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
- ClinicalTrials.gov ID
- NCT01360372
- Acronym / sponsor ID
- Drexel18538
- Conditions
- Tube Feeding
- Keywords
- Hydrogen breath test value and gastric residual volume measurements, Tube feeding tolerance while taking a stable dose of opiate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No eligible subjects identified
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 May 2011 (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.
It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.
Detailed description
Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone | Active comparator | Drug: Methylnaltrexone |
| saline placebo injection | Placebo comparator | Drug: Saline injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inadequate tube feeding rate of greater than equal to 40% below goal rate.
- Prescribed opiate therapy for pain or sedation, stable dose for minimum 48 hours
- Stable dose or no dose laxative for minimum 72 hours
Key exclusion criteria (6 listed)
- Unstable Hemodynamics (eg. vasopressor medication)
- Pregnancy
- End stage Renal Disease on Dialysis
- Plan to wean opiates in next 48 hours
- Known or suspected mechanical gastrointestinal 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 |
|---|---|---|
| MethylnaltrexoneMethylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight | Drug | Methylnaltrexone |
| Saline injectionSaline 0.4 to 0.8 ml injection | Drug | saline placebo injection |
Primary outcome
Hydrogen breath test measure of bowel transit
Time frame: 2 days
On day 1 Hydrogen Breath Test (HBT) measures will occur 30 minutes before test meal, immediately after test meal every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. On day 2 Hydrogen Breath test measures will occur 30 minutes before test meal, immediately after test meal and every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed.
1 secondary outcome
Gastric residual volume measurement
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylnaltrexone and Saline injection in people with Tube Feeding, run by Drexel University at 2 sites in United States.
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 6 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: withdrawn, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Hydrogen breath test measure of bowel transit (time frame: 2 days). 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 17 Mar 2015.