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Ketorol Gel in Gonarthrosis and Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638831
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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




Primary Outcome Measures :
  1. Change in pain on visual analogue scale (VAS) from baseline [ Time Frame: 10 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General inclusion criteria:

  1. Patients of both sexes in the age group from 20 to 70 years, who have signed informed consent for participation in the study.
  2. Understanding of spoken or written communication, adequate for being able to follow procedures of the Protocol and fill in documents related to the study.
  3. 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":

  1. Patients of both sexes in the age group from 40 to 70 years.
  2. Roentgenologically confirmed gonarthrosis (presence of roentgenological symptoms of osteophytes and stenosis of joint space).
  3. Intensity of pain in the knee joint as per visual analogue scale (VAS), when still: ≥40 mm, during movement: ≥ 50 mm.
  4. Presence of one of the under mentioned combinations of criteria:

    1. 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.
    2. 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.
    3. 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" :

  5. 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).
  6. 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.

    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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638831


Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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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
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02638831    
Other Study ID Numbers: DRL_RUS/PMS/2012/KETG
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Keywords provided by Dr. Reddy's Laboratories Limited:
Pain
Gonarthrosis
Low Back Pain
Ketorolac Tromethamine
Ketoprofen
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketorolac
Ketorolac Tromethamine
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action