Amtolmetin Gaucil in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— AGATA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865161
• Other study ID #: NISELAT-AGATA 2014
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2016
• Last updated: September 29, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• NISELAT
NISELAT 600MG BD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in WOMAC score from baseline	Reduced WOMAC (according to pain, rigidity and function scales) by > 20 % vs. baseline.	Baseline to 4 weeks	No
Secondary	Change in VAS		Baseline to 45 weeks	No
Secondary	SODA Questionnaire		Baseline to 4weeks	No
Secondary	No of adverse events	Total number of adverse events	Baseline to 4 week	Yes