Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-22 @ 4:29 PM
Study NCT ID:
NCT03687268
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2018-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
Sponsor:
Develco Pharma Schweiz AG
Organization:
Study Overview
Official Title:
Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase III Trial to Investigate the Efficacy, Safety and Tolerability of Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Naxos
Brief Summary:
Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily.
The trial will consist of four phases:
Screening phase (Week -4 to Week -3):
Confirmation phase (Week -2 to Week -1):
Double-blind treatment phase
Follow-up phase (Week 13-14):
The trial will consist of four phases:
Screening phase (Week -4 to Week -3):
Confirmation phase (Week -2 to Week -1):
Double-blind treatment phase
Follow-up phase (Week 13-14):
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: