Ketorol Gel in Gonarthrosis and Low Back Pain
|ClinicalTrials.gov Identifier: NCT02638831|
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gonarthrosis Low Back Pain||Drug: Ketorolac Tromethamine Drug: Ketoprofen||Phase 4|
This is a Comparative evaluation of therapeutic efficacy and safety of use of drug Ketorolac tromethamine gel and drug Ketoprofen gel , as an agent of local symptomatic therapy in patients with diseases of musculoskeletal system with associated pain syndrome in outpatient conditions.
The study includes patients with moderate pain syndrome in gonarthrosis and lower back pain (LBP).
The sample size of 240 was calculated for the main efficacy variable - mean pain intensity according to the visual analogue scale (VAS) in 10 days of therapy.
Patients who subjected to inclusion into the study and had signed informed consent will be distributed into the study groups depending on established diagnosis: Gonarthrosis group and LBP group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Randomized Study for Evaluating Efficacy and Safety of Ketorolac Tromethamine and Ketoprofen in Gel in Patients With Gonarthrosis and Low Back Pain|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Ketorolac Tromethamine
Ketorolac 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days
Drug: Ketorolac Tromethamine
Ketorolac tromethamine gel 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days
Active Comparator: Ketoprofen
Ketoprofen gel 2.5% for external application. Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days
Ketoprofen gel 2.5% for external application Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days
- Change in pain on visual analogue scale (VAS) from baseline [ Time Frame: 10 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638831
|Principal Investigator:||Nadezhda A Shostak, PhD||1 Russian National Research Medical Institute State Budgetary Institution of Higher Professional Education "N.I. Pirogov Russian National Research Medical Institute" of the Ministry of Health of Russia|