Ketorol Gel in Gonarthrosis and Low Back Pain

Phase 4

Completed

• Conditions: Gonarthrosis; Low Back Pain
• Interventions: Drug: Ketorolac Tromethamine; Drug: Ketoprofen

• Registration Number: NCT02638831
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with Gonarthrosis and Low back pain.

Detailed Description

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

• 1. Feedback on Informed Consent Form signed by the patient for participation in the Study.

  2. Continuation of participation in the study is in conflict with the patient's interests.

  3. Occurrence of a serious adverse event in the patient, the relation of which to the administration of the drug under study is classified definite, probable or possible.

  4. Patient needs additional treatment which may affect the parameters of efficacy under study.

  5. Violations of the protocol, which in the opinion of the investigator or sponsor of the study, are significant for evaluation of results of the clinical trial.

  6. Discontinuation of the study by the sponsor. 7. Discontinuation of the study by the investigator. 8. Discontinuation of the study by the regulatory bodies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac Tromethamine	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
Ketoprofen	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

Primary Outcome Measures

Name	Time	Method
Change in pain on visual analogue scale (VAS) from baseline	10 days