TerminatedNCT02745353Updated Dec 9, 2019Results posted

Naloxegol in Cancer Opioid-Induced Constipation

A Phase 2 interventional study of naloxegol in Constipation, sponsored by Joseph Ma. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.

Sponsored by Joseph Ma · Phase 2, Interventional, and Treatment

Why this study was terminated

Couldn't enough accrue patients

Phase: Phase 2
Study type: Interventional
Enrollment: 7
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.

Read the detailed description

Opioid-induced constipation (OIC) is a common symptom in patients with cancer-related pain and requires burdensome self-titration of laxatives for prophylaxis and treatment. Consequently, naloxegol may have an important role in this setting. Naloxegol has been evaluated in relieving OIC with cancer patients in a randomized, double blind, placebo-controlled trial over 4 weeks with a 12-week extension phase. However, accrual was challenging and the trial was closed early. Given the complexity of cancer and its treatment, a key first step is to determine if evaluating naloxegol versus standard of care is feasible in the management of OIC in this setting.

Subjects will receive naloxegol 25mg daily or usual care for a 2-week initial treatment period followed by 3-day washout period, then a 2-week crossover treatment period where subjects will receive naloxegol or usual care. Treatment assignment during the initial and crossover treatment periods will be dictated by the randomization arm. Subjects will also have the option to participate in a 12-week extension phase of naloxegol.

Conditions studied

Constipation

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Keywords

Cancer
Constipation
Opioid

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 140 are open to participants now.

This study's enrollment of 7 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Joseph Ma is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Adults greater than or equal to 18 years old.
Eastern Cooperative Oncology Group (ECOG) less than or equal to 3.
Glomerular filtration rate (GFR) greater than or equal to 30 ml/min/1.73m2 by Modification of Diet in Renal Disease (MDRD).
Corrected serum calcium level less than or equal to 10.5 mg/dL.
Estimated life expectancy greater than or equal to 6 months.
Negative pregnancy test prior to initiating study treatment for females of childbearing potential.

Exclusion criteria

Exclusion Criteria:

Patients receiving the following medications within 3 days of Study Day 1 and/or are planned to receive throughout the duration of the study period: opioid antagonist, mixed antagonist, a strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitor, a moderate CYP3A4 and/or P-gp inhibitor, and/or a strong CYP3A4 inducer.
Concurrent total parenteral nutrition and/or use of metoclopramide.
Patients at high risk for bowel perforation.
Constipation that was not primarily caused by opioids in the investigator's medical opinion.
A condition that may have affected the permeability of the blood-brain barrier (e.g., known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy)
Patient has clinically active diverticular disease.
Past medical history of irritable bowel syndrome, signs of active gastrointestinal (GI) bleeding, acute surgical abdomen, bowel stents, indwelling peritoneal catheter, mechanical GI obstruction, fecal impaction, or fecal ostomy.
Patient has motility/neurologic disorders including autonomic failure (spinal cord lesions, tumor invasion of nerves) and/or poorly controlled endocrine/metabolic disorders (hypercalcemia, hypokalemia, diabetes, hypothyroidism), as determined by the investigator.
Uncontrolled cancer pain despite analgesic therapy

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 7 participants (actual)

Study arms

Active comparator
A
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
Drug: naloxegol
Active comparator
B
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
Drug: naloxegol

Interventions

Drugnaloxegol
Also known as: MOVANTIK

What researchers measure

Primary outcomes

Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
completion of treatment defined as participants receiving all single daily doses for 2 weeks
Time frame: 4 weeks

Results

Posted Sep 4, 2019

Participant flow

First Intervention (2 Weeks)

Participant flow — First Intervention (2 Weeks)
Milestone	A- Naloxegol/ Standard of Care	B- Standard of Care/ Naloxegol
Started	4	3
Completed	1	1
Not completed	3	2

Washout (3 Days)

Participant flow — Washout (3 Days)
Milestone	A- Naloxegol/ Standard of Care	B- Standard of Care/ Naloxegol
Started	1	1
Completed	1	1
Not completed	0	0

Second Intervention (2 Weeks)

Participant flow — Second Intervention (2 Weeks)
Milestone	A- Naloxegol/ Standard of Care	B- Standard of Care/ Naloxegol
Started	1	1
Completed	1	0
Not completed	0	1

Outcome measures

PrimaryNumber of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care

completion of treatment defined as participants receiving all single daily doses for 2 weeks

Time frame:: 4 weeks
Reported as:: Count of participants · Participants

Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
Participants	Arm A (Naloxegol/Standard of Care)	Arm B (Standard of Care/ Naloxego)
Naloxegol	4	3
Standard of Care	1	1

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Naloxegol	2/5 (40%)	3/5 (60%)	3/5 (60%)
Standard of Care	0/4 (0%)	1/4 (25%)	2/4 (50%)

Most frequent serious events

Most frequent serious events
Event	Naloxegol	Standard of Care
AnemiaBlood and lymphatic system disorders	2/5	0/4
HospitalizationSurgical and medical procedures	2/5	1/4
FeverImmune system disorders	1/5	0/4
platelet count decreasedBlood and lymphatic system disorders	1/5	0/4

Most frequent other events

Most frequent other events
Event	Naloxegol	Standard of Care
AnemiaBlood and lymphatic system disorders	1/5	1/4
HyperkalemiaBlood and lymphatic system disorders	0/5	1/4
HypoalbuminemiaBlood and lymphatic system disorders	1/5	0/4
FeverGeneral disorders	1/5	0/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	A- Naloxegol/Standard of Care	B - Standard of Care/Naloxegol	Total
<=18 years	0	0	0
Between 18 and 65 years	3	2	5
>=65 years	1	1	2

Sex: Female, Male
Sex: Female, Male(Participants)	A- Naloxegol/Standard of Care	B - Standard of Care/Naloxegol	Total
Female	2	1	3
Male	2	2	4

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	A- Naloxegol/Standard of Care	B - Standard of Care/Naloxegol	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	4	3	7
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	A- Naloxegol/Standard of Care	B - Standard of Care/Naloxegol	Total
United States	4	3	7

Study locations

1 site

UCSD Moores Cancer Center
La Jolla, California 92093, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 7, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02745353
Lead sponsor: Joseph Ma
Collaborators: AstraZeneca
Responsible party: Joseph Ma (Associate Clinical Professor, University of California, San Diego) — Sponsor-investigator
First posted: Apr 20, 2016
Start date: May 2016
Primary completion: Jun 22, 2017
Completion: Jun 22, 2017
Results posted: Sep 4, 2019
Last update: Dec 9, 2019

Study contacts

Joseph Ma, PharmD

principal investigator · UCSD

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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