Amtolmetin Gaucil in Knee Osteoarthritis

NCT ID: NCT02865161

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-12-31

Brief Summary

This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.

Detailed Description

Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable.

Amtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.

Conditions

Knee Osteoarthritis

Study Groups

NISELAT

Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg

NISELAT

Intervention Type: DRUG

NISELAT 600MG BD

Interventions

NISELAT

NISELAT 600MG BD

Intervention Type: DRUG

Other Intervention Names

AMTOLMETIN GAUCIL

Eligibility Criteria

Inclusion Criteria

1. Informed consent form for participation in the study;

2. KOA (based on ACR, 1987)

3. Age between 30-60 years old

4. Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)

5. Dyspeptic symptoms (according to SODA questionnaire)

6. Pain intensity in the investigated knee joint ≥ 40 mm according to VAS

7. Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.

Exclusion Criteria

1. Contraindications to amtolmetin guacil (according to patient information leaflet)

2. Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg

3. Signs of renal or hepatic failure;

4. Pregnancy, lactation or planning for pregnancy.

5. One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denisov L Nikolaevich, MD

Role: PRINCIPAL_INVESTIGATOR

Moscow, Federal State Budget Scientific Institution "Scientific Research Institute of Rheumatology named VA Nasonova"

Other Identifiers

NISELAT-AGATA 2014

Identifier Type: -

Identifier Source: org_study_id