Advertisement

Topics

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

2014-07-24 14:19:08 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Opioid Induced Constipation (OIC)

Intervention

placebo, NKTR-118

Location

Tennessee Valley Pain Consultants / Center for Pain Management
Huntsville
Alabama
United States
35801

Status

Completed

Source

Nektar Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:08-0400

Clinical Trials [1477 Associated Clinical Trials listed on BioPortfolio]

Study of Methylnaltrexone in Opioid-Induced Constipation Patients

This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation ...

Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pai...

A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation

The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation following repeat dose administration

A Study of NKTR-262 in Combination With NKTR-214 and With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies

Patients will receive intratumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration...

Study Evaluating the Safety of SC Methylnaltrexone in Treatment of Opioid-Induced Constipation

This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by SC injection and will be tested in...

PubMed Articles [10605 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of naloxegol for opioid-induced constipation assessed by specific opioid medication, opioid dose, and duration of opioid use.

Efficacy and safety of naloxegol, a peripherally acting µ-opioid receptor antagonist that significantly reduces opioid-induced constipation (OIC), were assessed for patient subgroups defined post hoc...

Pathophysiology, diagnosis, and management of opioid-induced constipation.

Opioids are potent analgesics used for the treatment of acute and chronic pain. Side-effects are common and among the most bothersome are those associated with opioid-induced bowel dysfunction, which ...

Efficacy of Lubiprostone for the Treatment of Opioid-Induced Constipation, Analyzed by Opioid Class.

To examine the efficacy and safety of lubiprostone for the treatment of opioid-induced constipation (OIC) in patients by opioid class received.

Impact of opioid-induced constipation on healthcare resource utilization and costs for cancer pain patients receiving continuous opioid therapy.

Opioid therapy is often associated with adverse effects, including opioid-induced constipation (OIC), in patients receiving opioids for cancer pain. This retrospective observational cohort study evalu...

Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients With Chronic Noncancer Pain: A Placebo Crossover Analysis: Erratum.

Medical and Biotech [MESH] Definitions

An opioid antagonist with properties similar to those of NALOXONE; in addition it also possesses some agonist properties. It should be used cautiously; levallorphan reverses severe opioid-induced respiratory depression but may exacerbate respiratory depression such as that induced by alcohol or other non-opioid central depressants. (From Martindale, The Extra Pharmacopoeia, 30th ed, p683)

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections.

A class of opioid receptors recognized by its pharmacological profile. Kappa opioid receptors bind dynorphins with a higher affinity than endorphins which are themselves preferred to enkephalins.

A class of opioid receptors recognized by its pharmacological profile. Mu opioid receptors bind, in decreasing order of affinity, endorphins, dynorphins, met-enkephalin, and leu-enkephalin. They have also been shown to be molecular receptors for morphine.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...


Searches Linking to this Trial