Ketorol Gel in Gonarthrosis and Low Back Pain

NCT02638831 | Completed Phase 4

• 1 other identifier: DRL_RUS/PMS/2012/KETG
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gonarthrosis; Low Back Pain

Keywords

Pain; Gonarthrosis; Low Back Pain; Ketorolac Tromethamine; Ketoprofen

Outcome Measures

Primary Outcomes (1)

• Change in pain on visual analogue scale (VAS) from baseline

  10 days

Study Arms (2)

Ketorolac Tromethamine

EXPERIMENTAL

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

Ketoprofen

ACTIVE COMPARATOR

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

Interventions

Ketorolac Tromethamine DRUG

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

Ketorolac Tromethamine

Ketoprofen DRUG

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Low Back Pain; Pain

Interventions

Ketorolac Tromethamine; Ketoprofen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 23, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 13, 2017

Record last verified: 2017-03