Opioid-Induced ConstipationPhase 3NCT01186770

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

A Phase 3 study testing Methylnaltrexone in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. at 2 sites in United States.

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

MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-Induced Constipation
What is being tested?: Methylnaltrexone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 804 participants
Where: 2 sitesUnited States
Study dates: 1 Sep 2010to 8 Sep 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit.
Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month.
No known history of chronic constipation prior to the initiation of opioid therapy.
Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods..

Who cannot join

Prior treatment with oral MNTX.
Prior treatment with SC MNTX within 30 days of screening.
Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate.
Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PRA International
Raleigh, North Carolina, 27612
PRA, Intl.
Raleigh, North Carolina, 27612

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain

Conditions: Opioid-Induced Constipation
Being tested: Methylnaltrexone, Placebo
Keywords: Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain
Medical subject headings: Opioid-Induced Constipation

What participants receive

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

MethylnaltrexoneDrug
Also called Relistor
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
PlaceboDrug
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.

Study groups in NCT01186770
Study group	Role	What they receive
MNTX 150 mg	Experimental	Participants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks). Receives: Drug: Methylnaltrexone; Drug: Placebo
MNTX 300 mg	Experimental	Participants will receive MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks). Receives: Drug: Methylnaltrexone; Drug: Placebo
MNTX 450 mg	Experimental	Participants will receive MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks). Receives: Drug: Methylnaltrexone
Placebo	Placebo comparator	Participants will receive 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks). Receives: Drug: Placebo

What is being measured

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

Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4
RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.
Measured: Weeks 1 to 4

Secondary outcomes (2)

Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4
A responder was defined as at least 3 RFBMs/week, with an increase of at least 1 RFBM/week over baseline, for at least 3 out of the first 4 weeks of the treatment period. Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.
Measured: Weeks 1 to 4
Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing
Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.
Measured: Baseline, Weeks 1 to 4

Timeline

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

1 Sep 20108 Sep 2011

First posted23 Aug 2010 (estimated)
Study start1 Sep 2010
Primary completion8 Sep 2011
Study completion8 Sep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid-Induced ConstipationStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 804 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01186770
Sponsor's protocol ID: MNTX 3201
Status last verified: Sep 2019
First submitted: 19 Aug 2010
Last updated: 6 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
PubMed 33788162

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

RecruitingPhase 4
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Constipation, Opioid-Induced
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
RecruitingPhase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
Not yet recruitingPhase 3
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
OIC
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)

All Opioid-Induced Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain
ClinicalTrials.gov ID: NCT01186770
Acronym / sponsor ID: MNTX 3201
Conditions: Opioid-Induced Constipation
Keywords: Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 804 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Collaborators: Progenics Pharmaceuticals, Inc.
Study start: 1 Sep 2010 (actual)
Primary completion: 8 Sep 2011 (actual)
Study completion: 8 Sep 2011 (actual)
First posted: 23 Aug 2010 (estimated)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
MNTX 150 mg	Experimental	Drug: Methylnaltrexone, Drug: PlaceboParticipants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks).
MNTX 300 mg	Experimental	Drug: Methylnaltrexone, Drug: PlaceboParticipants will receive MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
MNTX 450 mg	Experimental	Drug: MethylnaltrexoneParticipants will receive MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit.
Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month.
No known history of chronic constipation prior to the initiation of opioid therapy.
Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods..

Key exclusion criteria (5 listed)

Prior treatment with oral MNTX.
Prior treatment with SC MNTX within 30 days of screening.
Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate.
Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.

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
MethylnaltrexoneAlso: RelistorMethylnaltrexone will be administered as per the dose and schedule specified in the respective arms.	Drug	MNTX 150 mg, MNTX 300 mg, MNTX 450 mg
PlaceboPlacebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.	Drug	MNTX 150 mg, MNTX 300 mg, Placebo

Primary outcome

Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4
Time frame: Weeks 1 to 4
RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.

2 secondary outcomes

Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4
Time frame: Weeks 1 to 4
Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing
Time frame: Baseline, Weeks 1 to 4

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MNTX 150 mg	201	160
MNTX 300 mg	202	156
MNTX 450 mg	200	148
Placebo	201	143

Primary outcome: Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4

Time frame: Weeks 1 to 4. Mean (Standard Deviation). Unit: percentage of days

Measure	MNTX 150 mg n = 201	MNTX 300 mg n = 201	MNTX 450 mg n = 200	Placebo n = 201
Value	21.05 (20.116)	24.64 (21.311)	27.40 (23.453)	18.18 (16.995)

MNTX 150 mg vs Placebo: Least square (LS) mean difference: 2.83 (95% CI -1.21 to 6.86), p = 0.1692, ANCOVA
MNTX 300 mg vs Placebo: LS mean difference: 6.51 (95% CI 2.47 to 10.55), p = 0.0016, ANCOVA
MNTX 450 mg vs Placebo: LS mean difference: 9.13 (95% CI 5.09 to 13.18), p < 0.0001, ANCOVA

Population analysed: ITT population included all randomized participants who received at least 1 dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day 1) up to Day 98. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MNTX 150 mg	5 of 201 (2.5%)	38 of 201 (18.9%)	Not reported
MNTX 300 mg	6 of 201 (3%)	35 of 201 (17.4%)	Not reported
MNTX 450 mg	4 of 200 (2%)	42 of 200 (21%)	Not reported
Placebo	8 of 201 (4%)	32 of 201 (15.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33788162Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.

Related trials for Opioid-Induced Constipation

RecruitingPhase 4
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RecruitingObservational study
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RecruitingPhase 1/2
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RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
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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.

Lindsey Mathew study director

Bausch Health Americas, Inc.

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 in people with Opioid-Induced Constipation, run by Bausch Health Americas, Inc. 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 4 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 6 Sep 2019. 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?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4 (time frame: Weeks 1 to 4). 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 NCT01186770, 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 6 Sep 2019.