Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01384292

First received: June 28, 2011

Last updated: September 28, 2012

Last verified: September 2012

History of Changes

Purpose

The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).

Condition	Intervention	Phase
Opioid-Induced Constipation	Drug: NKTR-118 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain

Resource links provided by NLM:

MedlinePlus related topics: Cancer Constipation

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Response to study drug, defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. [ Time Frame: Will be collected daily through the 4-week treatment period. ] [ Designated as safety issue: No ]
Response (responder/non-responder) to study drug, where a responder is defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.

Secondary Outcome Measures:

Part A and Part B: Change from baseline in RFBMs/week [ Time Frame: Will be collected daily through the 4-week treatment period as well as the 12 week extension ] [ Designated as safety issue: No ]
Part A and Part B: mean number of days per week with at least 1 RFBM. [ Time Frame: Will be collected daily through the 4-week treatment period as well as athe 12 week extension ] [ Designated as safety issue: No ]
Part A: Time (in hours) to first post-dose RFBM [ Time Frame: Will be collected daily through the 4-week treatment period part A only. ] [ Designated as safety issue: No ]
Part A: Change from baseline in the degree of straining associated with RFBMs during the 4-week placebo-controlled treatment period. [ Time Frame: Will be collected daily through the 4-week treatment period part A only. ] [ Designated as safety issue: No ]
Part A: Change from baseline in stool consistency (BSS) during the 4-week placebo-controlled treatment period. [ Time Frame: Will be collected daily through the 4-week treatment period .part A only. ] [ Designated as safety issue: No ]
Part A: Percentage of days with complete evacuation during the 4-week placebo-controlled treatment period. [ Time Frame: Will be collected daily through the 4-week treatment period part A only. ] [ Designated as safety issue: No ]
Part A and B: Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) total score and each domain score for Weeks 2 and 4. [ Time Frame: Part A: Will be evaluated at Visits 3, 5 and 6. Part B: will be evaluated at Visits 4 and 6. ] [ Designated as safety issue: No ]

Enrollment:	336
Study Start Date:	June 2011
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 (part A and B) Oral treatment	Drug: NKTR-118 12.5 mg oral tablet once daily
Experimental: 2 (part A and B) Oral treatment	Drug: NKTR-118 25 mg oral tablet once daily
Placebo Comparator: 3 (part A only) Oral treatment	Drug: Placebo Oral treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent prior to any study-specific procedures.
Men and women aged 18 or older.
Histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids.
Self-reported active symptoms of OIC at screening (<3 RFBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (<3 RFBMs/week on average aver the 2-week OIC confirmation period.
Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.

Exclusion Criteria:

Patients receiving Opioid regimen for treatment of pain other than related to cancer.
Any condition that may have affected the permeability of the blood-brain barrier, eg, known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy.
Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are excluded. Patients with multiple myeloma will be allowed.
Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with suspected clinically relevant radiation-induced injury of small or large intestine are excluded.
Pregnancy or lactation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384292

Hide Study Locations

Locations

United States, Alabama
Research Site
Huntsville, Alabama, United States
United States, Arizona
Research Site
Casa Grande, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
United States, Arkansas
Research Site
Fort Smith, Arkansas, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
North Little Rock, Arkansas, United States
United States, California
Research Site
Encino, California, United States
Research Site
Fountain Valley, California, United States
Research Site
Gilroy, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Montebello, California, United States
Research Site
Orange, California, United States
Research Site
Riverside, California, United States
Research Site
San Bernandino, California, United States
United States, Colorado
Research Site
Aurora, Colorado, United States
Research Site
Denver, Colorado, United States
United States, Florida
Research Site
Baypines, Florida, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Celebration, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Lake Worth, Florida, United States
Research Site
Lakeland, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Naples, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Tavares, Florida, United States
United States, Georgia
Research Site
Albany, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Riverdale, Georgia, United States
Research Site
Roswell, Georgia, United States
United States, Hawaii
Research Site
Honolulu, Hawaii, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
United States, Indiana
Research Site
Anderson, Indiana, United States
Research Site
Evansville, Indiana, United States
United States, Kentucky
Research Site
Owensboro, Kentucky, United States
United States, Louisiana
Research Site
Lafayette, Louisiana, United States
United States, Maryland
Research Site
Elkridge, Maryland, United States
Research Site
Hollywood, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Research Site
Fairhaven, Massachusetts, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
Research Site
Kalamazoo, Michigan, United States
United States, Mississippi
Research Site
Southaven, Mississippi, United States
United States, Missouri
Research Site
Jefferson City, Missouri, United States
Research Site
St. Louis, Missouri, United States
United States, Montana
Research Site
Missoula, Montana, United States
United States, Nebraska
Research Site
Omaha, Nebraska, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
United States, New Jersey
Research Site
Toms River, New Jersey, United States
Research Site
Voorhees, New Jersey, United States
United States, New York
Research Site
Great Neck, New York, United States
Research Site
Syracuse, New York, United States
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States
Research Site
Flat Rock, North Carolina, United States
Research Site
Morrisville, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-salem, North Carolina, United States
United States, North Dakota
Research Site
Bismarck, North Dakota, United States
United States, Ohio
Research Site
Akron, Ohio, United States
Research Site
Beavercreek, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Middleton, Ohio, United States
United States, Pennsylvania
Research Site
Danville, Pennsylvania, United States
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States
United States, Texas
Research Site
Beaumont, Texas, United States
Research Site
Bellaire, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Lubbock, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Sugarland, Texas, United States
United States, Virginia
Research Site
Fairfax, Virginia, United States
Australia, New South Wales
Research Site
Broadmeadow, New South Wales, Australia
Australia, Victoria
Research Site
Frankston, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Australia, Western Australia
Research Site
Fremantle, Western Australia, Australia
Belgium
Research Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Mons, Belgium
Research Site
Wetteren, Belgium
Bulgaria
Research Site
Haskovo, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Ruse, Bulgaria
Research Site
Shumen, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Croatia
Research Site
Zagreb, Croatia
Czech Republic
Research Site
Benesov, Czech Republic
Research Site
Ceske Budejovice, Czech Republic
Research Site
Praha 2, Czech Republic
Germany
Research Site
Berlin, BE, Germany
Research Site
Wiesbaden, HE, Germany
Research Site
Hamburg, HH, Germany
Research Site
Offenbach, Germany
Poland
Research Site
Brzozow, Poland
Research Site
Bydgoszcz, Poland
Research Site
Gdansk, Poland
Research Site
Gliwice, Poland
Research Site
Poznan, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Puerto Rico
Research Site
Ponce, Puerto Rico
Romania
Research Site
Craiova, Dolj, Romania
Research Site
Ploiesti, Prahova, Romania
Research Site
Baia Mare, Romania
Research Site
Braila, Romania
Research Site
Brasov, Romania
Research Site
Bucuresti, Romania
Research Site
Cluj-napoca, Romania
Research Site
Onesti, Romania
Slovakia
Research Site
Bardejov, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Kosice, Slovakia
Research Site
Presov, Slovakia
South Africa
Research Site
Port Elizabeth, Eastern Cape, South Africa
Research Site
Bloemfontein, Free State, South Africa
Research Site
Benoni, Gauteng, South Africa
Research Site
Pretoria, Gauteng, South Africa
Research Site
Vereeniging, Gauteng, South Africa
Research Site
Durban, Kz-natal, South Africa
Research Site
Goodwood, W Cape, South Africa
Spain
Research Site
Sevilla, Andalucia, Spain
Research Site
Valencia, Comunidad Valenciana, Spain
Research Site
A Coruna, Galicia, Spain
United Kingdom
Research Site
Penarth, CRF, United Kingdom
Research Site
Norwich, Norfolk, United Kingdom
Research Site
Guildford, Surrey, United Kingdom
Research Site
Chippenham, Wilts, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01384292 History of Changes
Other Study ID Numbers:	D3820C00006, 2011-001985-16
Study First Received:	June 28, 2011
Last Updated:	September 28, 2012
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Slovakia: State Institute for Drug Control South Africa: Medicine Control Council Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Romania: National Medicines Agency (ANM) Poland: Ministry of Health and Social Welfare Croatia: Agency for Medicinal Product and Medical Devices

Keywords provided by AstraZeneca:

Cancer-Related Pain
Opioid-Induced Constipation
OIC

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 21, 2013

To Top