NCT04083651 is a Phase 2, PHASE3 clinical trial of Methylnaltrexone bromide in Pancreatic Cancer, sponsored by Bausch Health Americas, Inc..

Who is sponsoring NCT04083651?

NCT04083651 is sponsored by Bausch Health Americas, Inc..

What drugs are being tested in NCT04083651?

Interventions in NCT04083651: Methylnaltrexone bromide, Placebo.

What condition does NCT04083651 study?

NCT04083651 studies Pancreatic Cancer.

Is NCT04083651 still recruiting?

NCT04083651 is currently withdrawn. Last updated 7 May 2021.

Last reviewed 2021-05-07 · How we verify

NCT04083651

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer

Withdrawn Phase 2, PHASE3 Last updated 7 May 2021

What this trial tests

Phase 2, PHASE3 trial testing Methylnaltrexone bromide in Pancreatic Cancer. Withdrawn.

Timeline

6 January 2020

Primary endpoint
15 October 2023

15 October 2023

Quick facts

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	6 January 2020
Primary completion	15 October 2023
Estimated completion	15 October 2023
Sites	1 location across United States

Drugs / interventions tested

Methylnaltrexone bromide — full drug profile →
Placebo

Conditions studied

Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an adaptive design study. During the first phase of the study, participants will be randomized in 2:1 ratio to receive either MNTX 450 milligrams (mg) once daily (QD) or placebo. An interim analysis will be performed for futility and at that point a higher dosage regimen may be utilized for the active treatment group if the futility criteria are met. For the second stage of the study, interim analyses will be conducted for futility and sample size reassessment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Methylnaltrexone bromide

Trials testing the same drug.

NCT00640146 — Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation Afte · Phase 2 · completed

Other recruiting trials for Pancreatic Cancer

Currently open trials in the same condition.

NCT07126158 — Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma · Phase 2 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07439757 — AI-Powered Precision Decision-Making for Pancreatic Diseases · recruiting
NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
NCT07236177 — B-GLUCANCER2 : A Pilot Study Evaluating a New Method for Cancer Detection by Measuring the Activity of Different Glycosi · EARLY_PHASE1 · recruiting

Other Bausch Health Americas, Inc. trials

Trials by the same sponsor.

NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
NCT07428538 — Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) · Phase 3 · recruiting
NCT05098028 — Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease · Phase 2 · completed
NCT05027282 — Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatm · NA · completed
NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04083651 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bausch Health Americas, Inc.
Last refreshed: 7 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04083651.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing