Amtolmetin Gaucil in Knee Osteoarthritis (AGATA)

Open-label, Multicenter, Observational (Non-interventional) Study of Efficacy and Tolerability of Amtolmetin GuAcil in Subjects With Knee osTeoArthrosis With Dyspepsia. (AGATA)

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: NISELAT

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.

• Study Type: Observational
• Enrollment (Actual): 220

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with knee osteoarthrosis (KOA)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NISELAT; Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg	Drug: NISELAT; NISELAT 600MG BD; Other Names: AMTOLMETIN GAUCIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in WOMAC score from baseline	Reduced WOMAC (according to pain, rigidity and function scales) by > 20 % vs. baseline.	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS		Baseline to 45 weeks
SODA Questionnaire		Baseline to 4weeks
No of adverse events	Total number of adverse events	Baseline to 4 week

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Denisov L Nikolaevich, MD, Moscow, Federal State Budget Scientific Institution "Scientific Research Institute of Rheumatology named VA Nasonova"

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (ESTIMATE): August 12, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NISELAT-AGATA 2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Under review