Ketorol Gel in Gonarthrosis and Low Back Pain

Sponsor

Dr. Reddy's Laboratories Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT02638831

Collaborator

(none)

240

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gonarthrosis Low Back Pain	Drug: Ketorolac Tromethamine Drug: Ketoprofen	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Mar 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: 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

Arm

Intervention/Treatment

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

Drug: 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

Outcome Measures

Primary Outcome Measures

Change in pain on visual analogue scale (VAS) from baseline [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

General inclusion criteria:

Patients of both sexes in the age group from 20 to 70 years, who have signed informed consent for participation in the study.
Understanding of spoken or written communication, adequate for being able to follow procedures of the Protocol and fill in documents related to the study.
For women: patients who are not pregnant, not breast-feeding. The female patients must be in either the post-climacteric period or surgically sterile, or for the entire period of the study use contraceptive methods with a reliability level of higher than 90%. Methods of contraception with higher than 90% level of reliability of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, oral contraceptives.

Criteria of inclusion in the group "gonarthrosis":

Patients of both sexes in the age group from 40 to 70 years.
Roentgenologically confirmed gonarthrosis (presence of roentgenological symptoms of osteophytes and stenosis of joint space).
Intensity of pain in the knee joint as per visual analogue scale (VAS), when still: ≥40 mm, during movement: ≥ 50 mm.
Presence of one of the under mentioned combinations of criteria:
Pain in the knee joint during the last one month, accompanied by crepitation in active movement of the joint, morning stiffness up to 30 min, age - 38 years and older.
Pain in the knee joint during the last one month, accompanied by crepitation in active movement of the joint, morning stiffness up to 30 min., bone enlargements in the joint area.
Pain in knee joint during the last one month in the absence of crepitation, bone enlargements in joint area

Criteria of inclusion in the group "low backpain" :

Patients of both sexes in the age group of 20 to 65 years with acute pain syndrome in the lower part of the back (less than 12 weeks).
Intensity of pain in the back as per VAS when still ≥40 mm, during movement ≥ 50 mm.

Exclusion Criteria:

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

Continuation of participation in the study is in conflict with the patient's interests.
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.
Patient needs additional treatment which may affect the parameters of efficacy under study.
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.
Discontinuation of the study by the sponsor. 7. Discontinuation of the study by the investigator. 8. Discontinuation of the study by the regulatory bodies.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dr. Reddy's Laboratories Limited

Investigators

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