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Opioid Antagonist

Arm 1 for Constipation

Phase 3
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Eligible Conditions
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.

Side effects data

From 2013 Phase 4 trial • 156 Patients • NCT00672139
26%
Disease progression
23%
Abdominal pain
19%
Diarrhea
18%
Asthenia
18%
Oedema peripheral
16%
Confusional state
14%
Fall
12%
Dyspnoea
12%
Contusion
11%
Urinary tract infection
9%
Agitation
9%
Nausea
7%
Rales
7%
Dizziness
7%
Vomiting
7%
Decreased appetite
7%
Lethargy
7%
Anxiety
7%
Dehydration
5%
Dysphagia
5%
Flatulence
5%
Cough
5%
Anemia
5%
Back pain
5%
Fatigue
5%
Restlessness
5%
Laceration
2%
Cerebrovascular accident
2%
Sepsis
2%
Myocardial infarction
2%
Femoral neck fracture
2%
Hip fracture
2%
Chest pain
2%
Pyrexia
2%
Thrombocytopenia
2%
Cardiac failure congestive
2%
Constipation
2%
General physical health deterioration
2%
Pain
2%
Pneumonia aspiration
2%
Renal failure
2%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Methylnaltrexone Bromide 8 mg
Methylnaltrexone Bromide 12 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
Group II: Arm 2Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylnaltrexone
FDA approved

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,902 Total Patients Enrolled
28 Trials studying Constipation
13,202 Patients Enrolled for Constipation
Wyeth is now a wholly owned subsidiary of PfizerIndustry Sponsor
625 Previous Clinical Trials
248,305 Total Patients Enrolled
3 Trials studying Constipation
570 Patients Enrolled for Constipation
Tage Ramakrishna, MDStudy DirectorProgenics Pharmaceuticals, Inc.
18 Previous Clinical Trials
1,196 Total Patients Enrolled
1 Trials studying Constipation
154 Patients Enrolled for Constipation
~6 spots leftby Oct 2025
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