Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Opioid-Induced Constipation (OIC) Clinical Trial

Official title:

An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336205
• Other study ID #: D3820C00008
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2011
• Last updated: October 13, 2014
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• Provision of written informed consent prior to any study-specific procedures.

• NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.

• PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.

• FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 first study visit 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 a risk to the patient.

• Pregnancy or lactation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation (OIC)

Intervention

Drug:
• NKTR-118
25 mg oral tablet once daily
• Usual care
As prescribed by the investigator

Locations

Country	Name	City	State
United States	Research Site	Akron	Ohio
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alpharetta	Georgia
United States	Research Site	Anderson	South Carolina
United States	Research Site	Arcadia	California
United States	Research Site	Athens	Alabama
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beavercreek	Ohio
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bloomington	Illinois
United States	Research Site	Boise	Idaho
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Brooksville	Florida
United States	Research Site	Calamazoo	Michigan
United States	Research Site	Centerville	Ohio
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Chiefland	Florida
United States	Research Site	Chino	California
United States	Research Site	Clarksville	Tennessee
United States	Research Site	Clearwater	Florida
United States	Research Site	Clifton	New Jersey
United States	Research Site	Clinton	Utah
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Maryland
United States	Research Site	Columbus	Georgia
United States	Research Site	Council Bluffs	Iowa
United States	Research Site	Crystal River	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Debary	Florida
United States	Research Site	Deerfield Beach	Florida
United States	Research Site	Delray Beach	Florida
United States	Research Site	Downingtown	Pennsylvania
United States	Research Site	Edgewater	Florida
United States	Research Site	Elkin	North Carolina
United States	Research Site	Encino	California
United States	Research Site	Eustis	Florida
United States	Research Site	Evansville	Indiana
United States	Research Site	Flat Rock	North Carolina
United States	Research Site	Fort Myers	Florida
United States	Research Site	Freehold	New Jersey
United States	Research Site	Fremont	Nebraska
United States	Research Site	Fremont	California
United States	Research Site	Garden Grove	California
United States	Research Site	Garden Grove	Arizona
United States	Research Site	Goodyear	Arizona
United States	Research Site	Great Neck	New York
United States	Research Site	Greer	South Carolina
United States	Research Site	Harrisburg	North Carolina
United States	Research Site	Hartsdale	New York
United States	Research Site	Henderson	Nevada
United States	Research Site	Hollywood	Maryland
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Park	California
United States	Research Site	Huntsville	Alabama
United States	Research Site	Hurst	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Inverness	Florida
United States	Research Site	Jackson	Florida
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jenkintown	Pennsylvania
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	Jupiter	Florida
United States	Research Site	Kansas City	Kansas
United States	Research Site	La Mesa	California
United States	Research Site	Laguna Hills	California
United States	Research Site	Lakewood	California
United States	Research Site	Lansing	Kansas
United States	Research Site	Largo	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lauderhill	Florida
United States	Research Site	Lexington	Texas
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Lumberton	New Jersey
United States	Research Site	Marietta	Georgia
United States	Research Site	Marshall	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Mesa	Arizona
United States	Research Site	Miami	Florida
United States	Research Site	Middleton	Wisconsin
United States	Research Site	Milan	Tennessee
United States	Research Site	Mobile	Alabama
United States	Research Site	Mooresville	North Carolina
United States	Research Site	Morganton	North Carolina
United States	Research Site	Morrisville	North Carolina
United States	Research Site	Myrtle Beach	South Carolina
United States	Research Site	Naples	Florida
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New Tazewell	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Norristown	Pennsylvania
United States	Research Site	North Little Rock	Arkansas
United States	Research Site	North Massapequa	New York
United States	Research Site	North Miami	Florida
United States	Research Site	Ocala	Florida
United States	Research Site	Oceanside	California
United States	Research Site	Ogden	Utah
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange	California
United States	Research Site	Orange City	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Oviedo	Florida
United States	Research Site	Pasadena	California
United States	Research Site	Pell City	Alabama
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Peoria	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pikesville	Maryland
United States	Research Site	Pinellas Park	Florida
United States	Research Site	Plantation	Florida
United States	Research Site	Port Orange	Florida
United States	Research Site	Port St. Lucie	Florida
United States	Research Site	Pottstown	Pennsylvania
United States	Research Site	Reisterstown	Maryland
United States	Research Site	Richmond	Virginia
United States	Research Site	Riverside	California
United States	Research Site	Saint George	Utah
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Bernardino	California
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	Santa Ana	California
United States	Research Site	Schaumburg	Illinois
United States	Research Site	Sherwood	Arkansas
United States	Research Site	Shreveport	Louisiana
United States	Research Site	South Miami	Florida
United States	Research Site	Springfield	Virginia
United States	Research Site	St Louis	Missouri
United States	Research Site	St. Doral	Florida
United States	Research Site	St. Louis	Missouri
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Stamford	Connecticut
United States	Research Site	Sugarland	Texas
United States	Research Site	Suwanee	Georgia
United States	Research Site	Tamarac	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Toms River	New Jersey
United States	Research Site	Traverse City	Michigan
United States	Research Site	Tucker	Georgia
United States	Research Site	Tucson	Arizona
United States	Research Site	Tuscon	Arizona
United States	Research Site	Victoria	Texas
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Walnut Creek	California
United States	Research Site	Watertown	Massachusetts
United States	Research Site	West Jordan	Utah
United States	Research Site	West Palm	Florida
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Whittier	California
United States	Research Site	Wichita	Kansas
United States	Research Site	Willingboro	New Jersey
United States	Research Site	Winston-salem	North Carolina
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Patients Experiencing at Least One Adverse Event (AE)	The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.	Baseline (Week 0) to end of the follow-up period	Yes
Primary	Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)	The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.	Baseline (Week 0) to end of the follow-up period	Yes
Primary	Incidence of Patients Experiencing Severe Adverse Events (SAEs)	The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.	Baseline (Week 0) to end of the follow-up period	Yes

External Links

•   Clinical_Study_Report_Synopsis_D3820C00008