Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT00239395
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.
Study:
NCT00239395
Study Brief:
Protocol Section:
NCT00239395