Clinical trial NCT01395524: A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Official title: A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain
Opioid-Induced Constipation.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.


Eligibility criteria: Inclusion Criteria:

* Must have completed the 12-week study D3820C00004 through Visit 8.
* Provision of written informed consent prior to any study-specific procedures.
* Men and women who were between the ages of \>18 and \<85 years at the time of the screening visit for study D3820C00004.
* Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.
* Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

* Patients receiving opioid regimen for treatment of pain related to cancer.
* History of cancer within 5 years from the screening visit of study D3820C00004 with the exception of basal cell cancer and squamous cell skin cancer.
* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
* Other issues related to the gastrointestinal tract that could impose risk to the patient.
* Pregnancy or lactation.

Primary outcomes:
measure: Incidence of Patients Experiencing at Least One Adverse Event (AE)
timeFrame: Baseline (Week 0) to end of the follow-up period (Week 14)
measure: Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
timeFrame: Baseline (Week 0) to end of the follow-up period (Week 14)
measure: Incidence of Patients Experiencing Severe Adverse Events (SAEs)
timeFrame: Baseline (Week 0) to end of the follow-up period (Week 14)
Secondary outcomes:
measure: Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
timeFrame: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
measure: Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
timeFrame: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Calera
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Malvern
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Burbank
country: United States
facility: Research Site
state: California
city: Garden Grove
country: United States
facility: Research Site
state: California
city: Laguana Hills
country: United States
facility: Research Site
state: California
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Gatos
country: United States
facility: Research Site
state: California
city: Montebello
country: United States
facility: Research Site
state: California
city: National City
country: United States
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state: California
city: Norwalk
country: United States
facility: Research Site
state: California
city: Paramount
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Brooksville
country: United States
facility: Research Site
state: Florida
city: Crystal River
country: United States
facility: Research Site
state: Florida
city: Deland
country: United States
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state: Florida
city: Fort Myers
country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jupiter
country: United States
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state: Florida
city: Maitland
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Naples
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Ormond Beach
country: United States
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state: Florida
city: Pembroke Pines
country: United States
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state: Florida
city: Plantation
country: United States
facility: Research Site
state: Florida
city: Tamarac
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
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state: Florida
city: Venice
country: United States
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state: Florida
city: West Palm Beach
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Boise
country: United States
facility: Research Site
state: Idaho
city: Bloomington
country: United States
facility: Research Site
state: Illinois
city: Rockford
country: United States
facility: Research Site
state: Illinois
city: Avon
country: United States
facility: Research Site
state: Indiana
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Reserach Site
state: Indiana
city: West Des Moines
country: United States
facility: Research Site
state: Iowa
city: Pikesville
country: United States
facility: Research Site
state: Maryland
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Biloxi
country: United States
facility: Research Site
state: Mississippi
city: St Joseph
country: United States
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state: Missouri
city: St Louis
country: United States
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state: Missouri
city: Missoula
country: United States
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state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Trenton
country: United States
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state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Morrisville
country: United States
facility: Research Site
state: North Carolina
city: Beavercreek
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Medord
country: United States
facility: Research Site
state: Oregon
city: Feasterville
country: United States
facility: Research Site
state: Pennsylvania
city: Huntingdon Valley
country: United States
facility: Research Site
state: Pennsylvania
city: Levittown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Yardley
country: United States
facility: Research Site
state: Pennsylvania
city: Cumberland
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Clarksville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Doral
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: North Richland Hills
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Broadmeadow
country: Australia
facility: Research Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Research Site
state: New South Wales
city: Port Kembla
country: Australia
facility: Research Site
state: New South Wales
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Greenslopes
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Fremantle
country: Australia
facility: Research Site
state: Western Australia
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Potsdam
country: Germany
facility: Research Site
state: BR
city: Dietzenbach
country: Germany
facility: Research Site
state: HE
city: Huttenberg
country: Germany
facility: Research Site
state: HE
city: Wetzlar
country: Germany
facility: Research Site
state: HE
city: Hamburg
country: Germany
facility: Research Site
state: HH
city: Schwerin
country: Germany
facility: Research Site
state: MV
city: Celle
country: Germany
facility: Research Site
state: NI
city: Hannover
country: Germany
facility: Research Site
state: NI
city: Essen
country: Germany
facility: Research Site
state: NW
city: Mainz
country: Germany
facility: Research Site
state: RP
city: Kiel
country: Germany
facility: Research Site
state: SH
city: Leipzig
country: Germany
facility: Research Site
state: SN
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mark Sostek
role: STUDY_DIRECTOR
References:
citation: Webster L, Tummala R, Diva U, Lappalainen J. A 12-week extension study to assess the safety and tolerability of naloxegol in patients with noncancer pain and opioid-induced constipation. J Opioid Manag. 2016 Nov/Dec;12(6):405-419. doi: 10.5055/jom.2016.0360.
citation: Lawson R, King F, Marsh K, Altincatal A, Cimen A. Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility. Adv Ther. 2016 Aug;33(8):1331-46. doi: 10.1007/s12325-016-0365-y. Epub 2016 Jun 24.