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

Opioid-Induced Constipation (OIC) Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Constipation
Opioid-Induced Constipation (OIC)

Clinical Trial Details

NCT number	NCT01309841
Study type	Interventional
Source	AstraZeneca
Contact
Status	Completed
Phase	Phase 3
Start date	March 2011
Completion date	August 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01333540` - A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation	Phase 2
Completed	`NCT01323790` - Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation	Phase 3
Completed	`NCT01395524` - 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	Phase 3
Recruiting	`NCT05588323` - Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids	Phase 1/Phase 2
Completed	`NCT01336205` - Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation	Phase 3