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

This study is ongoing, but not recruiting participants.

First Received: January 11, 2008 Last Updated: March 11, 2009 History of Changes

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

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
Primary Completion Date:	March 2009 (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 and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

18 years of age or older, 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 less than 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

Show 33 Study Locations

Sponsors and Collaborators

Nektar Therapeutics

More Information

No publications provided

Responsible Party:	Nektar Therapeutics ( Lorianne Masuoka, MD )
Study ID Numbers:	07-IN-NX003
Study First Received:	January 11, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00600119 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Germany: BfArM; Romania: Romanian MOH

Keywords provided by Nektar Therapeutics:

NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Central Nervous System Depressants

Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid
Naloxone

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Constipation

Central Nervous System Depressants
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 06, 2009