Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426647
Status:
COMPLETED
Last Update Posted:
2010-02-01
First Post:
2007-01-23
Brief Title:
Norspan Patches Versus Tramadol in Subjects With Chronic Moderate to Severe Osteoarthritis Pain in the Hip Knee andor Lumbar Spine
Sponsor:
Norpharma AS
Organization:
Norpharma AS
Study Overview
Official Title:
A Randomised Double-blind Multicentre Equivalence Study With Active Parallel Comparator Group to Evaluate the Efficacy and Safety of Norspan Patches Versus Tramadol in Subjects With Chronic Moderate to Severe Osteoarthritis Pain in the Hip Knee or Lumbar Spine
Status:
COMPLETED
Status Verified Date:
2010-01
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:
The primary objective of this equivalence study is to evaluate the efficacy of Norspan patches versus Tramadol in subjects with chronic moderate to severe osteoarthritis pain of the hip knee andor lumbar spine
The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups
The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups
Detailed Description:
This is a randomised double-blind multicentre equivalence study with active comparator parallel group to evaluate the efficacy and safety of Norspan patches versus Tramadol in subjects with OA pain in hip knee andor lumbar spine currently receiving sub-optimal analgesic treatment defined as BS-11 score 4 when treated with paracetamol 4000 mgday or another analgesic at least comparable to this
The study consist of 4 phases
Run-in Wash-out Double blind and Follow-up
The study consist of 4 phases
Run-in Wash-out Double blind and Follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NORTOP | None | None | None |