Opioid Induced Constipation (OIC)Phase 2NCT00600119

A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

A Phase 2 study testing NKTR-118 in people with Opioid Induced Constipation (OIC), run by AstraZeneca at 33 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

Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Induced Constipation (OIC)
What is being tested?: NKTR-118
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 33 sitesUnited States
Study dates: Dec 2007to Apr 2009
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

Main Inclusion Criteria:

18 years of age or older, male or female
Receiving a stable opioid regimen
Documented opioid-induced constipation
Willingness to stop all laxatives and other bowel regimens. The use of constipation rescue medication will be allowed during the study.

Main Exclusion Criteria:

Life expectancy less than 6 months
Active substance abuse
Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea or intermittent loose stools or constipation
Pregnant or breast-feeding
Any receipt of an investigational medication within 30 days of screening
History or presence of specific cardiac, neurologic, endocrine and/or psychiatric conditions

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

United States33 sites

Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, 29621
PMI Health Research Group
Atlanta, Georgia, 30312
Gulf Coast Reserach
Baton Rouge, Louisiana, 70808
Millennium Pain Center
Bloomington, Illinois, 61701
Northwest Clinical Trials
Boise, Idaho, 83704
Gabrail Cancer Center
Canton, Ohio, 44718
ClinSearch, LLC
Chattanooga, Tennessee, 37421
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610
Southeast Clinical Research
Chiefland, Florida, 32626
Riverhills Healthcare Research Division
Cincinnati, Ohio, 45219
Midwest Pharmaceutical Research, Inc.
City of Saint Peters, Missouri, 63376
MAPS Applied Research Center
Edina, Minnesota, 55435
Centennial Medical Group
Elkridge, Maryland, 21075
Four Seasons Hospice and Palliative Care
Flat Rock, North Carolina, 28731
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Tennessee Valley Pain Consultants / Center for Pain Management
Huntsville, Alabama, 35801
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46254
Therapeutic Research Institute of Orange County
Laguna Hills, California, 92653
Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503
Arapahoe Gastroenterology, PC
Littleton, Colorado, 80120
Medford Medical Clinic
Medford, Oregon, 97504
Osler Medical, Inc. / Osler Clinical Research
Melbourne, Florida, 32901
Singleton Health Center
Orangeburg, South Carolina, 29118
Deerfoot Internal Medicine
Pinson, Alabama, 35126
Lifetree Clinical Research
Salt Lake City, Utah, 84106
San Diego Managed Care Group
San Diego, California, 92128
Spokane Internal Medicine
Spokane, Washington, 99216
Genova Clinical Research, Inc.
Tucson, Arizona, 85741
Options Health Research
Tulsa, Oklahoma, 74104
Palm Beach Research Center
West Palm Beach, Florida, 33409
Gold Coast Research LLC
Weston, Florida, 33324
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)

Conditions: Opioid Induced Constipation (OIC)
Being tested: placebo, NKTR-118
Keywords: NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
Medical subject headings: Opioid-Induced Constipation, Constipation

What participants receive

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

placeboDrug
placebo, oral, once daily (QD)
NKTR-118Drug
5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Study groups in NCT00600119
Study group	Role	What they receive
A	Placebo comparator	Placebo Receives: Drug: placebo
B	Experimental	NKTR-118 Receives: Drug: NKTR-118

What is being measured

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

Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
Measured: Days 1 through 7

Secondary outcomes (3)

Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
Measured: Days 1 through 28
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
Measured: Days 1 through 28
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
Measured: Days 1 through 28

Timeline

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

Dec 2007Apr 2009

First posted24 Jan 2008 (estimated)
Study startDec 2007
Primary completionMar 2009
Study completionApr 2009

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 Opioid Induced Constipation (OIC)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00600119
Sponsor's protocol ID: 07-IN-NX003
Status last verified: May 2015
First submitted: 11 Jan 2008
Last updated: 12 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 (OIC) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)
ClinicalTrials.gov ID: NCT00600119
Acronym / sponsor ID: 07-IN-NX003
Conditions: Opioid Induced Constipation (OIC)
Keywords: NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Nektar Therapeutics
Study start: Dec 2007
Primary completion: Mar 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 24 Jan 2008 (estimated)
Results: Posted 12 Jun 2015

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A	Placebo comparator	Drug: placeboPlacebo
B	Experimental	Drug: NKTR-118NKTR-118

Who may qualify

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

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
placeboplacebo, oral, once daily (QD)	Drug	A
NKTR-1185 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)	Drug	B

Primary outcome

Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
Time frame: Days 1 through 7
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.

3 secondary outcomes

Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
Time frame: Days 1 through 28
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Time frame: Days 1 through 28
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Time frame: Days 1 through 28

Results and safety

Results posted to the registry on 12 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo 5 mg	36	32
NKTR-118 5 mg	35	33
Placebo 25 mg	29	27
NKTR-118 25 mg	31	30
Placebo 50 mg	39	37
NKTR-118 50 mg	37	35

Primary outcome: Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1

Time frame: Days 1 through 7. Mean (Standard Deviation). Unit: Number of SBMs/week

Measure	Placebo 5 mg n = 31	NKTR-118 5 mg n = 31	Placebo 25 mg n = 27	NKTR-118 25 mg n = 29	Placebo 50 mg n = 37	NKTR-118 50 mg n = 30
Value	1.8 (2.4)	2.6 (3.6)	1.9 (2.5)	3.6 (2.3)	1.9 (5.2)	4.4 (3.8)

Placebo 5 mg vs NKTR-118 5 mg: p = 0.7781, Wilcoxon (Mann-Whitney)
Placebo 25 mg vs NKTR-118 25 mg: p = 0.0020, Wilcoxon (Mann-Whitney)
Placebo 50 mg vs NKTR-118 50 mg: p = 0.0001, Wilcoxon (Mann-Whitney)

Population analysed: The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NKTR-118 25 mg	1 of 30 (3.3%)	19 of 30 (63.3%)	Not reported
NKTR-118 5 mg	1 of 33 (3%)	18 of 33 (54.5%)	Not reported
NKTR-118 50 mg	1 of 35 (2.9%)	26 of 35 (74.3%)	Not reported
Placebo 25 mg	0 of 27 (0%)	15 of 27 (55.6%)	Not reported
Placebo 5 mg	1 of 32 (3.1%)	15 of 32 (46.9%)	Not reported
Placebo 50 mg	1 of 37 (2.7%)	13 of 37 (35.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
07-IN-NX003 CSR Synopsis.pdfLink provided by the sponsor.

Related trials for Opioid Induced Constipation (OIC)

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)

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.

Mark Sostek study director

AstraZeneca Pharmaceuticals, Wilm DE

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NKTR-118 in people with Opioid Induced Constipation (OIC), run by AstraZeneca at 33 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?

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 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 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 12 Jun 2015). 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?

Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1 (time frame: Days 1 through 7). 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 NCT00600119.

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 12 Jun 2015.