ConstipationPhase 2NCT02745353
Naloxegol in Cancer Opioid-Induced Constipation
A Phase 2 study testing naloxegol in people with Constipation, run by Joseph Ma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- naloxegol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 22 Jun 2017
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: A Phase II, Randomized, Single Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid-Induced Constipation in Cancer Patients
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
- Constipation
- Being tested
- naloxegol
- Keywords
- Cancer, Constipation, Opioid
- Medical subject headings
- Constipation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxegolDrug
Also called MOVANTIK
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 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. Receives: Drug: naloxegol |
| B | Active comparator | 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. Receives: Drug: naloxegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
Why it stopped: Couldn't enough accrue patients
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.
- Other trials for ConstipationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Ma
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Joseph Ma, University of California, San Diego
- Investigators
- Joseph Ma, PharmD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745353
- Sponsor's protocol ID
- 160121
- Status last verified
- Dec 2019
- First submitted
- 15 Apr 2016
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Single Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid-Induced Constipation in Cancer Patients
- ClinicalTrials.gov ID
- NCT02745353
- Acronym / sponsor ID
- 160121
- Conditions
- Constipation
- Keywords
- Cancer, Constipation, Opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Couldn't enough accrue patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Joseph MaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- May 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 4 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: naloxegolPatients 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. |
| B | Active comparator | Drug: naloxegolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| naloxegolAlso: MOVANTIK | Drug | A, B |
Primary outcome
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
Time frame: 4 weeks
completion of treatment defined as participants receiving all single daily doses for 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Ma, PharmD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naloxegol in people with Constipation, run by Joseph Ma at 1 site 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Dec 2019. 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 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?
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2019.