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

Opioid-Induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01384292
• Other study ID #: D3820C00006
• Secondary ID: 2011-001985-16
• Status: Terminated
• Phase: Phase 3
• First received: June 28, 2011
• Last updated: May 28, 2015
• Start date: June 2011
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesSlovakia: State Institute for Drug ControlSouth Africa: Medicine Control CouncilSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyRomania: National Medicines Agency (ANM)Poland: Ministry of Health and Social WelfareCroatia: Agency for Medicinal Product and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• NKTR-118
12.5 mg oral tablet once daily
• NKTR-118
25 mg oral tablet once daily
• Placebo
Oral treatment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Croatia,  Czech Republic,  Germany,  Poland,  Puerto Rico,  Romania,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response (Responder/Non-responder) to Study Drug	Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.	Baseline to Week 4	No

External Links

•   Clinical_Study_Report_Synopsis_D3820C00006