NKTR-118

DRUG11 trials

Sponsors

AstraZeneca

Conditions

Amount of NKTR-118 in BloodBioavailabilityDrug Induced ConstipationDrug- Drug InteractionsHealthyHealthy VolunteersHepatic; Functional DisturbanceOpioid Induced Constipation (OIC)

Phase 1

Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects

CompletedNCT01318655

AstraZenecaHealthy

Start: 2011-03-31End: 2011-07-31Updated: 2011-08-25

A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects

CompletedNCT01325415

AstraZenecaAmount of NKTR-118 in Blood, Variation in the Heart's Electrical Cycle

Start: 2011-04-30End: 2011-07-31Updated: 2014-10-15

Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function

CompletedNCT01392807

AstraZenecaHepatic; Functional Disturbance

Start: 2011-07-31End: 2011-11-30Updated: 2014-10-15

Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118

CompletedNCT01520896

AstraZenecaBioavailability, Drug- Drug Interactions, Healthy Volunteers

Start: 2012-02-29End: 2012-04-30Updated: 2014-10-15

Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118

CompletedNCT01533870

AstraZenecaDrug Induced Constipation

Start: 2012-03-31End: 2012-05-31Updated: 2014-10-15

Phase 2

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

CompletedNCT00600119

AstraZenecaOpioid Induced Constipation (OIC)

Start: 2007-12-31End: 2009-04-30Updated: 2015-06-12

Phase 3

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

CompletedNCT01309841

AstraZenecaOpioid-Induced Constipation (OIC)

Start: 2011-03-31End: 2012-08-31Updated: 2015-06-01

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

CompletedNCT01323790

AstraZenecaOpioid-Induced Constipation (OIC)

Start: 2011-03-31End: 2012-09-30Updated: 2015-06-02

Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

CompletedNCT01336205

AstraZenecaOpioid-Induced Constipation (OIC)

Start: 2011-04-30End: 2012-12-31Updated: 2014-10-20

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

TerminatedNCT01384292

AstraZenecaOpioid-Induced Constipation

Start: 2011-06-30End: 2012-09-30Updated: 2015-06-01

A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

CompletedNCT01395524

AstraZenecaOpioid-Induced Constipation (OIC)

Start: 2011-07-31End: 2012-09-30Updated: 2017-02-23

Related Papers

Efficacy and Safety of Naloxegol in Patients with Chronic Non-Cancer Pain Who Experience Opioid-Induced Constipation: A Pooled Analysis of Two Global, Randomized Controlled Studies.

2023-08-28

S179 Naloxegol Provides Clinically Meaningful Symptom Improvement (PAC-SYM) in Patients With Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Global Phase 3 Studies of Naloxegol

The American Journal of Gastroenterology2022-10-01

S164 Naloxegol Provides Clinically Meaningful Healthcare-Related Quality of Life (HR-QoL) Improvement (PAC-QOL) in Patients With Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Global Phase 3 Studies of Naloxegol

The American Journal of Gastroenterology2022-10-01

S497 Naloxegol Accelerates Time to First Spontaneous Bowel Movement (SBM) and Complete SBM (CSBM) With Predictable Efficacy in Patients With Extreme Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Phase 3 Trials

The American Journal of Gastroenterology2021-10-01

S508 Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms in Patients With Extreme OIC: A Pooled Analysis of Two Pivotal Phase 3 Trials

The American Journal of Gastroenterology2021-10-01

Treatment with Naloxegol Versus Placebo: Pain Assessment in Patients with Noncancer Pain and Opioid-Induced Constipation.

2017-11-2713 citations

Translating Clinical Findings into the Patient's Perspective: Post-hoc Pooled Analysis of Bowel Movement Changes as a Predictor of Improvement in Patients' Opioid-induced Constipation Symptoms and Outcomes.

2016-12-0610 citations

A 12-week extension study to assess the safety and tolerability of naloxegol in patients with noncancer pain and opioid-induced constipation.

2016-11-0118 citations

Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility.

2016-06-241 citations

Efficacy and safety of naloxegol in patients with opioid‐induced constipation and laxative‐inadequate response

United European Gastroenterology Journal2015-09-0851 citations

Naloxegol for Opioid-Induced Constipation in Patients with Noncancer Pain

New England Journal of Medicine2014-06-04329 citations

Evaluation of the Effect of Naloxegol on Cardiac Repolarization: A Randomized, Placebo- and Positive-Controlled Crossover Thorough QT/QTc Study in Healthy Volunteers

Clinical Therapeutics2013-11-1328 citations

Long-term Safety and Tolerability of Naloxegol in Patients with Opioid-induced Constipation

The American Journal of Gastroenterology2013-10-013 citations

Naloxegol Symptom Responder Rates in Patients with Opioid-induced Constipation: Results from Two Prospective, Randomized Controlled Trials

The American Journal of Gastroenterology2013-10-013 citations

Efficacy of Naloxegol in a Subpopulation of Patients with Opioid-induced Constipation and an Inadequate Baseline Response to Laxatives: Results from Two Prospective, Randomized Controlled Trials

The American Journal of Gastroenterology2013-10-01