Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02934061
Status:
COMPLETED
Last Update Posted:
2018-01-16
First Post:
2016-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy and Safety of Tizaspray® Versus Sirdalud®, in Patients With Acute Low Back Pain
Sponsor:
MDM S.p.A.
Organization:
Study Overview
Official Title:
A Phase III, Multicenter, Randomized Study to Assess the Efficacy and Safety of 0,5 mg Tizaspray® Administered Intranasally Versus Sirdalud® 2 mg Tablets, in Patients With Acute Low Back Pain
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
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:
None
Brief Summary:
Open label, randomized, controlled, multicenter study with two parallel groups of patients
Detailed Description:
This is a phase III, open label, randomized, controlled, multicenter study with two parallel groups of patients.
Tizaspray® 0.5 mg (a new pharmaceutical form, liquid nasal spray solution), is proposed in this trial as a ready to use treatment for short term therapy of painful muscle spasms as the acute low back pain.
Tizaspray® 0.5 mg (a new pharmaceutical form, liquid nasal spray solution), is proposed in this trial as a ready to use treatment for short term therapy of painful muscle spasms as the acute low back pain.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: