Colonic InertiaPhase 4NCT00949377
Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
A Phase 4 study testing Methylnaltrexone Bromide (MNTX) in people with Colonic Inertia, run by Beth Israel Medical Center.
Trial summary
The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Inertia
- What is being tested?
- Methylnaltrexone Bromide (MNTX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2011
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and greater
- Clinical diagnosis of constipation
- Any patients that report taking an opioid analgesic for greater than two (2) weeks (eg known oncology patients and chronic pain syndrome patients, including those with low back pain or sciatica)
- Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry.
- All patients will have a flat and upright abdominal x-ray, and chest x-ray to exclude gastrointestinal (GI) obstruction. Any patients who have radiographic evidence of GI obstruction will need a CT scan of the abdomen to exclude GI obstruction prior to study enrollment.
- Females of childbearing potential must have a negative pregnancy test and must be encouraged to use appropriate birth control for a period after the study.
- Willing to comply with study instructions and sign an informed consent
Who cannot join
- Pregnancy or lactation
- Recent surgery within six (6) weeks of the emergency department visit
- Opioid withdrawal syndrome as determined by clinical judgment.
- Patients with previous history of diabetic gastroparesis.
- Any patient who has known or suspected gastrointestinal obstruction
- Any patients with creatinine clearance ≤ 30 mL/min
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- Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism.
- Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs.
- Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
- A known history of substance abuse on methadone maintenance therapy > 12 months
- Allergy or contraindication to use of methylnaltrexone
- Prior enrollment in study
About this study
The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.
- Conditions
- Colonic Inertia
- Being tested
- Methylnaltrexone Bromide (MNTX), Placebo
- Keywords
- Constipation, opioid
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylnaltrexone Bromide (MNTX)Drug
Also called Relistor
The recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg.
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Methylnaltrexone Bromide | Experimental | Not described Receives: Drug: Methylnaltrexone Bromide (MNTX) |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laxation
Measured: 4 hours
Secondary outcomes (1)
Opioid withdrawal symptoms
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Unable to recruit enough patients at a single center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic InertiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Lemeneh Tefera, MD, Principal investigator, Beth Israel Medical CenterMichael Heller, MD, Study director, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949377
- Sponsor's protocol ID
- 064-09
- Status last verified
- Apr 2015
- First submitted
- 29 Jul 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
- ClinicalTrials.gov ID
- NCT00949377
- Acronym / sponsor ID
- 064-09
- Conditions
- Colonic Inertia
- Keywords
- Constipation, opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit enough patients at a single center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jul 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 investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone Bromide | Experimental | Drug: Methylnaltrexone Bromide (MNTX) |
| Normal Saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 and greater
- Clinical diagnosis of constipation
- Any patients that report taking an opioid analgesic for greater than two (2) weeks (eg known oncology patients and chronic pain syndrome patients, including those with low back pain or sciatica)
- Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry.
- All patients will have a flat and upright abdominal x-ray, and chest x-ray to exclude gastrointestinal (GI) obstruction. Any patients who have radiographic evidence of GI obstruction will need a CT scan of the abdomen to exclude GI obstruction prior to study enrollment.
Key exclusion criteria (12 listed)
- Pregnancy or lactation
- Recent surgery within six (6) weeks of the emergency department visit
- Opioid withdrawal syndrome as determined by clinical judgment.
- Patients with previous history of diabetic gastroparesis.
- Any patient who has known or suspected 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 |
|---|---|---|
| Methylnaltrexone Bromide (MNTX)Also: RelistorThe recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. | Drug | Methylnaltrexone Bromide |
| PlaceboNormal saline | Drug | Normal Saline |
Primary outcome
Laxation
Time frame: 4 hours
1 secondary outcome
Opioid withdrawal symptoms
Time frame: 36 hours
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 14 Oct 2015.
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.
Lemeneh Tefera, MD principal investigator
Beth Israel Medical Center
Michael Heller, MD study director
Beth Israel Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylnaltrexone Bromide (MNTX) in people with Colonic Inertia, run by Beth Israel Medical Center.
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 7 inclusion and 12 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 14 Oct 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?
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 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?
Laxation (time frame: 4 hours). 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 14 Oct 2015.