Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT00239395
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Randomised, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg IM Ampoules Once Daily and Meloxicam 7.5 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With Osteoarthritis (OA)
Status:
COMPLETED
Status Verified Date:
2013-10
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 objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
Detailed Description:
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
The primary endpoint: Pain on active movement,
The secondary endpoint:
* Pain at rest
* Patient status with regard to change of arthritic condition assessed by the patient/investigator
* Patient's assessment of arthritic condition
* Onset of action
* Time to maximum pain relief
* Paracetamol consumption
* Withdrawals due to inadequate efficacy
* Final global assessment of efficacy by the patient/investigator
Safety endpoints
* Local tolerability assessment of the injections by the patient/investigator
* Patient's /Investigator's assessment of overall tolerability
* Number, nature and severity of adverse events
* Laboratory investigations
* Withdrawals due to safety reasons
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet).
The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
Study Hypothesis:
The null hypothesis of interest is that the primary endpoint for meloxicam ampoule is inferior to oral meloxicam. The alternative is that meloxicam ampoule is noninferior to the oral meloxicam .
Comparison(s):
The primary endpoint of the study was to assess pain on active movement by VAS prior and after the treatment.
The primary endpoint: Pain on active movement,
The secondary endpoint:
* Pain at rest
* Patient status with regard to change of arthritic condition assessed by the patient/investigator
* Patient's assessment of arthritic condition
* Onset of action
* Time to maximum pain relief
* Paracetamol consumption
* Withdrawals due to inadequate efficacy
* Final global assessment of efficacy by the patient/investigator
Safety endpoints
* Local tolerability assessment of the injections by the patient/investigator
* Patient's /Investigator's assessment of overall tolerability
* Number, nature and severity of adverse events
* Laboratory investigations
* Withdrawals due to safety reasons
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet).
The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
Study Hypothesis:
The null hypothesis of interest is that the primary endpoint for meloxicam ampoule is inferior to oral meloxicam. The alternative is that meloxicam ampoule is noninferior to the oral meloxicam .
Comparison(s):
The primary endpoint of the study was to assess pain on active movement by VAS prior and after the treatment.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: