Intestinal ObstructionPhase 1LOP-MNTX-2009NCT01596777

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects

A Phase 1 study testing Loperamide, Methylnaltrexone 12 mg sc. and Methylnaltrexone IR capsule in people with Intestinal Obstruction, run by University Medicine Greifswald at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to describe the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and measure pharmacokinetics of methylnaltrexone after subcutaneous and oral administration of immediate release and extended release capsules. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Intestinal Obstruction
What is being tested?: Loperamide, Methylnaltrexone 12 mg sc. and Methylnaltrexone IR capsule
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteGermany
Study dates: Jan 2010to May 2010
Phase: 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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

age: 18 - 45 years
sex: male and female
ethnic origin: Caucasian
minimal body weight: 62 kg
body mass index: ≥ 19 kg/m² and ≤ 27 kg/m²
good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which were judged by the clinical investigator not to differ in a clinical relevant way from the normal state
written informed consent

Who cannot join

hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
gastrointestinal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
drug or alcohol dependence
positive drug or alcohol screening
smokers of 10 or more cigarettes per day
positive results in HIV, HBV and HCV screenings

Show all 20Show fewer

volunteers who were on a diet which could affect the pharmacokinetics of the drug
heavy tea or coffee drinkers (more than 1 L per day)
lactation, pregnancy test positive or not performed or women of child-bearing age without safe contraception
volunteers suspected or known not to follow instructions of the clinical investigators
volunteers who were unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they would have been exposed to as a result of their participation in the study
volunteers liable to orthostatic dysregulation, fainting or blackouts
participation in a clinical trial during the last 3 months prior to the start of the study
less than 14 days after last acute disease
less than 3 months after last blood donation
any medication within 4 weeks prior to the intended first administration of the study medication which might have influenced functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors)
any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-live of the respective drug (except oral contraceptives)
intake of grapefruit containing food or beverages within 14 days prior to administration of the study medication
known allergic reactions to the active ingredients used or to constituents of the study medication
deficiency of glucose-6-phosphate dehydrogenase

Trial locations and contacts

1 site in 1 country.

Germany1 site

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald
Greifswald, Mecklenburg-Vorpommern

Other trials in Germany

About this study

Read the detailed description

The increasing prevalence of opioid use and consequently, opioid-induced bowel dysfunction has prompted interest in identifying effective treatment options. Until now, the treatment of opioid-induced constipation (OIC) has been viewed as an extension of constipation in general. Traditional therapies for constipation such as bulking agents, stool softeners, stimulant laxatives, and osmotic agents are commonly utilized, but the effects of such therapies are nonspecific and are often generating diarrhea or cramps and some of these drugs cause severe side effects. Furthermore, these conventional measures are sometimes insufficient in some patients, especially those requiring increasing doses of opioids.

Opioid-induced constipation is predominantly mediated by gastrointestinal μ-opioid receptors. Selective blockade of these peripheral receptors might relieve constipation without compromising centrally mediated effects of opioid analgesia or precipitating withdrawal.

Naloxone is a competitive antagonist of opioid receptors inside and outside the central nervous system used as a solution for injection in the treatment of opioid overdose. When administered orally, it can reduce opioid-induced constipation due to a local action in the gut.

Another way to prevent central actions is the use of opioid antagonists which can't penetrate the blood-brain barrier such as methylnaltrexone and alvimopan. Their antagonism of μ-opioid receptors in the gastrointestinal tract seems to reverse opioid-induced gut hypomotility.

It is assumed that methylnaltrexone after oral administration influences intestinal motility by local blockade of opioid receptors along the luminal surface of the gut. Because methylnaltrexone seems to have an absorption window in the proximal small intestine as caused by lower activity of P-glycoprotein in that region (similar to other quaternary compounds, eg. trospium chloride), immediate release (uncoated) methylnaltrexone is better absorbed form the small intestine and might therefore be less active than the enteric-coated drug.

However, the pharmacokinetic and pharmacodynamic data on oral methylnaltrexone are very preliminarily so far. Furthermore, intestinal transit time has been measured using lactulose as a probe compound that has an own laxative effect.

Therefore, the following clinical study was initiated to proof the concept in a controlled clinical trial in healthy subjects, whether methylnaltrexone antagonizes the loperamide induced delay of oro-cecal and whole-gut transit time after oral administration of immediate and extended release capsules in comparison to subcutaneous administration.

Loperamide is an opioid agonist and acts on the µ-receptors in the myenteric plexus. It does not affect the central nervous system like other opioids. Loperamide significantly prolongs the mouth-to-cecum transit time as evaluated by the lactulose hydrogen breath test. This effect may be antagonized by the concomitant administration of naloxone.

Conditions: Intestinal Obstruction
Being tested: Loperamide, Loperamide placebo, Methylnaltrexone placebo, Methylnaltrexone 12 mg sc., Methylnaltrexone IR capsule
Keywords: Loperamide-induced obstipation, Methylnaltrexone, oro-cecal transit time, whole gut transit time, Pharmacokinetics
Medical subject headings: Intestinal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LoperamideDrug
Also called LOP 4 mg
20 ml Loperamid-ratiopharm® Lösung (ratiopharm) in 180 ml apple juice prepared before administration
Loperamide placeboDrug
Also called LOP placebo
200 ml apple juice
Methylnaltrexone placeboDrug
Also called MNTX placebo
Methylnaltrexone placebo capsule (identical to MNTX IR and MNTX ER)
Methylnaltrexone 12 mg sc.Drug
Also called MNTX 12 mg sc.
RELISTOR 12 mg/0.6 ml Injektionslösung (Wyeth)
Methylnaltrexone IR capsuleDrug
Also called MNTX IR
Methylnaltrexone bromide 500 mg IR capsule
Methylnaltrexone ER capsuleDrug
Also called MNTX ER
Methylnaltrexone bromide 500 mg ER capsule
Colon TransitDevice
3x1 capsules containing radio-opaque marker of 6 different shapes (in two consecutive study periods, capsules with different shapes of the markers are given)
SulfasalazineDrug
Also called SSP
500 mg Azulfidine® (Pharmacia)

Study groups in NCT01596777
Study group	Role	What they receive
Treatment A	Placebo comparator	Administration of LOP placebo (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX placebo (0 h). To asses the oro-cecal and whole-gut transit time under placebo condition. Receives: Drug: Loperamide placebo; Drug: Methylnaltrexone placebo; Device: Colon Transit; Drug: Sulfasalazine
Treatment B	Placebo comparator	Administration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX placebo (0 h). To asses the oro-cecal and whole-gut transit time under loperamide-induced obstipation condition. Receives: Drug: Loperamide; Drug: Methylnaltrexone placebo; Device: Colon Transit; Drug: Sulfasalazine
Treatment C	Active comparator	Administration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX 12 mg sc. (0 h). To assess the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and to measure pharmacokinetics of methylnaltrexone after subcutaneous administration. Receives: Drug: Loperamide; Drug: Methylnaltrexone 12 mg sc.; Device: Colon Transit; Drug: Sulfasalazine
Treatment D	Active comparator	Administration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX IR (0 h). To assess the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and to measure pharmacokinetics of methylnaltrexone after oral administration of immediate release capsule. Receives: Drug: Loperamide; Drug: Methylnaltrexone IR capsule; Device: Colon Transit; Drug: Sulfasalazine
Treatment E	Active comparator	Administration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX ER (0 h). To assess the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and to measure pharmacokinetics of methylnaltrexone after oral administration of extended release capsule. Receives: Drug: Loperamide; Drug: Methylnaltrexone ER capsule; Device: Colon Transit; Drug: Sulfasalazine

What is being measured

The primary outcome is the main question the study is designed to answer.

Oro-cecal transit time
Oro-cecal transit time (OCT) was defined as the first appearance of sulfapyridine in the blood after oral administration of 500 mg sulfasalazine immediate release tablets. Because of the high sensitivity of the analytical assay, the OCT was defined as the average of the times needed after sulfasalazine administration to exceed serum concentrations (cut-off) of 50 ng/ml (t50) and of 100 ng/ml (t100).
Measured: up to 24 h after administration of sulfasalazine
Average whole-gut transit time
Whole-gut transit time (WGT) was assessed by counting the appearance of radio-opaque markers of different shapes (Colon transit capsules) to different time pints in the stool, which were administered 24 h, 12 h and 1 h before administration of the methylnaltrexone study medication. The radio-opaque markers in the stool inside the sampling containers were visualized with an X-ray device (Philips Optimus, Philips Healthcare, Hamburg, Germany, CE 257303004) The images were stored and evaluated using the Agfa PACS Workstation, Impact-Version 5.2 (Agfa-Healthcare, Cologne, Germany).
Measured: up to 6 days after administration of methylnaltrexone
renal clearances (CLR)
Measured: blood sampling at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h and urine sampling in 24 hours interval for 3 days after administration of methylnaltrexone
area under the concentrations-time curve (AUC)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
maximum concentration (Cmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
time of maximum concentration (Tmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
terminal half-life (t1/2)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
mean residence time (MRT)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
distribution volume at steady-state (Vss)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
total body clearance (CLtot)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
relative bioavailability (F)
Ratio AUC of IR and ER formulation over subcutaneous administration
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010May 2010

First posted11 May 2012 (estimated)
Study startJan 2010
Primary completionMar 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intestinal ObstructionStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01596777
Sponsor's protocol ID: LOP-MNTX-2009
Acronym: LOP-MNTX-2009
Status last verified: Oct 2016
First submitted: 7 May 2012
Last updated: 26 Oct 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects
ClinicalTrials.gov ID: NCT01596777
Acronym / sponsor ID: LOP-MNTX-2009 / LOP-MNTX-2009
Conditions: Intestinal Obstruction
Keywords: Loperamide-induced obstipation, Methylnaltrexone, oro-cecal transit time, whole gut transit time, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University Medicine GreifswaldUniversity, hospital or other
Study start: Jan 2010
Primary completion: Mar 2010 (actual)
Study completion: May 2010 (actual)
First posted: 11 May 2012 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Treatment A	Placebo comparator	Drug: Loperamide placebo, Drug: Methylnaltrexone placebo, Device: Colon Transit, Drug: SulfasalazineAdministration of LOP placebo (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX placebo (0 h). To asses the oro-cecal and whole-gut transit time under placebo condition.
Treatment B	Placebo comparator	Drug: Loperamide, Drug: Methylnaltrexone placebo, Device: Colon Transit, Drug: SulfasalazineAdministration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX placebo (0 h). To asses the oro-cecal and whole-gut transit time under loperamide-induced obstipation condition.
Treatment C	Active comparator	Drug: Loperamide, Drug: Methylnaltrexone 12 mg sc., Device: Colon Transit, Drug: SulfasalazineAdministration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX 12 mg sc. (0 h). To assess the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and to measure pharmacokinetics of methylnaltrexone after subcutaneous administration.
Treatment D	Active comparator	Drug: Loperamide, Drug: Methylnaltrexone IR capsule, Device: Colon Transit, Drug: SulfasalazineAdministration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX IR (0 h). To assess the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and to measure pharmacokinetics of methylnaltrexone after oral administration of immediate release capsule.
Treatment E	Active comparator	Drug: Loperamide, Drug: Methylnaltrexone ER capsule, Device: Colon Transit, Drug: SulfasalazineAdministration of LOP 4 mg (-24 h, -12 h, -1 h, 12 h), Colon Transit (-24 h, -12 h, -1 h), SSP (+ 2 h) and MNTX ER (0 h). To assess the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and to measure pharmacokinetics of methylnaltrexone after oral administration of extended release capsule.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

age: 18 - 45 years
sex: male and female
ethnic origin: Caucasian
minimal body weight: 62 kg
body mass index: ≥ 19 kg/m² and ≤ 27 kg/m²

Key exclusion criteria (20 listed)

hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
gastrointestinal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
drug or alcohol dependence
positive drug or alcohol screening
smokers of 10 or more cigarettes per day

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
LoperamideAlso: LOP 4 mg20 ml Loperamid-ratiopharm® Lösung (ratiopharm) in 180 ml apple juice prepared before administration	Drug	Treatment B, Treatment C, Treatment D, Treatment E
Loperamide placeboAlso: LOP placebo200 ml apple juice	Drug	Treatment A
Methylnaltrexone placeboAlso: MNTX placeboMethylnaltrexone placebo capsule (identical to MNTX IR and MNTX ER)	Drug	Treatment A, Treatment B
Methylnaltrexone 12 mg sc.Also: MNTX 12 mg sc.RELISTOR 12 mg/0.6 ml Injektionslösung (Wyeth)	Drug	Treatment C
Methylnaltrexone IR capsuleAlso: MNTX IRMethylnaltrexone bromide 500 mg IR capsule	Drug	Treatment D
Methylnaltrexone ER capsuleAlso: MNTX ERMethylnaltrexone bromide 500 mg ER capsule	Drug	Treatment E
Colon Transit3x1 capsules containing radio-opaque marker of 6 different shapes (in two consecutive study periods, capsules with different shapes of the markers are given)	Device	Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
SulfasalazineAlso: SSP500 mg Azulfidine® (Pharmacia)	Drug	Treatment A, Treatment B, Treatment C, Treatment D, Treatment E

Primary outcome

Oro-cecal transit time
Time frame: up to 24 h after administration of sulfasalazine
Oro-cecal transit time (OCT) was defined as the first appearance of sulfapyridine in the blood after oral administration of 500 mg sulfasalazine immediate release tablets. Because of the high sensitivity of the analytical assay, the OCT was defined as the average of the times needed after sulfasalazine administration to exceed serum concentrations (cut-off) of 50 ng/ml (t50) and of 100 ng/ml (t100).
Average whole-gut transit time
Time frame: up to 6 days after administration of methylnaltrexone
Whole-gut transit time (WGT) was assessed by counting the appearance of radio-opaque markers of different shapes (Colon transit capsules) to different time pints in the stool, which were administered 24 h, 12 h and 1 h before administration of the methylnaltrexone study medication. The radio-opaque markers in the stool inside the sampling containers were visualized with an X-ray device (Philips Optimus, Philips Healthcare, Hamburg, Germany, CE 257303004) The images were stored and evaluated using the Agfa PACS Workstation, Impact-Version 5.2 (Agfa-Healthcare, Cologne, Germany).
renal clearances (CLR)
Time frame: blood sampling at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h and urine sampling in 24 hours interval for 3 days after administration of methylnaltrexone
area under the concentrations-time curve (AUC)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
maximum concentration (Cmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
time of maximum concentration (Tmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
terminal half-life (t1/2)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
mean residence time (MRT)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
distribution volume at steady-state (Vss)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
total body clearance (CLtot)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
relative bioavailability (F)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 16, 24 h after administration of methylnaltrexone
Ratio AUC of IR and ER formulation over subcutaneous administration

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 26 Oct 2016.

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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 1 study testing Loperamide, Methylnaltrexone 12 mg sc. and Methylnaltrexone IR capsule in people with Intestinal Obstruction, run by University Medicine Greifswald at 1 site in Germany.

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 20 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 26 Oct 2016. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Oro-cecal transit time (time frame: up to 24 h after administration of sulfasalazine). The study lists 11 primary outcomes in all. 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 NCT01596777.

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 26 Oct 2016.