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

Purpose

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 dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses. The study is currently active and plans to enroll approximately 224 patients at about 50 sites in the US, Canada and the EU.

Condition	Intervention	Phase
Opioid Induced Constipation (OIC)	Drug: placebo Drug: NKTR-118	Phase II

MedlinePlus related topics:

Constipation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy 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)

Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:

Increase in number of spontaneous bowel movements from baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dose-response, safety, tolerability, pharmacokinetics, other symptoms of OBD assessed using the Patient Assessment of Constipation Symptoms (PAC-SYM), QOL, measurements, and maintenance of opioid analgesic effect [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	224
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Placebo	Drug: placebo placebo, oral, once daily (QD)
B: Experimental NKTR-118	Drug: NKTR-118 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

18-70 years of age, 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 <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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600119

Contacts


Contact: John Dort	1 650 631 3100

Locations


United States, Florida
	Gold Coast Research LLC	Recruiting
	Plantation, Florida, United States
	Contact: Lynda Hale, RN, MBA 954-474-3331 LFH4321@Bellsouth.Net

United States, Georgia
	PMI Health Research Group	Recruiting
	Atlanta, Georgia, United States
	Contact: Alison Greely 404-525-5787
	Principal Investigator: Delaphine Head, MD

United States, Tennessee
	ClinSearch	Recruiting
	Chattanooga, Tennessee, United States
	Contact: Trenda Rector 423-698-4584
	Principal Investigator: Richard A Krause, MD

United States, Utah
	Lifetree Clinical Research	Recruiting
	Salt Lake City, Utah, United States, 84106
	Contact: Brooke King 801-269-8200 brookek@lifetreeresearch.com
	Principal Investigator: Lynn R. Webster, MD

Sponsors and Collaborators

Nektar Therapeutics

More Information

Responsible Party:	Nektar Therapeutics ( John Dort )
Study ID Numbers:	07-IN-NX003
First Received:	January 11, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00600119
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Signs and Symptoms

Signs and Symptoms, Digestive

Constipation

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Nektar Therapeutics
Information provided by:	Nektar Therapeutics
ClinicalTrials.gov Identifier:	NCT00600119