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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 has been completed.
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00600119
First received: January 11, 2008
Last updated: January 28, 2013
Last verified: January 2013
History of Changes

January 11, 2008
January 28, 2013
December 2007
March 2009   (final data collection date for primary outcome measure)
Increase in number of spontaneous bowel movements from baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00600119 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
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)

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Opioid Induced Constipation (OIC)
  • Drug: placebo
    placebo, oral, once daily (QD)
  • Drug: NKTR-118
    5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
  • Placebo Comparator: A
    Placebo
    Intervention: Drug: placebo
  • Experimental: B
    NKTR-118
    Intervention: Drug: NKTR-118
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
April 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00600119
07-IN-NX003
No
AstraZeneca
AstraZeneca
Nektar Therapeutics
Study Director: Mark Sostek AstraZeneca Pharmaceuticals, Wilm DE
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP