NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain

NCT04612283 | Completed Phase 2 DMC

• 1 other identifier: NUTRIN004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis is characterized by the breakdown of cartilage in joints. As cartilage deteriorates, the bones of the joint begin to run against one another, causing stiffness and pain, which often impairs movement. Osteoarthritis also can damage ligaments, menisci, and muscles. Bone or cartilage fragments may float in the joint space, causing irritation and pain. Bone spurs, or osteophytes, may also develop, causing additional pain and potentially damaging surrounding tissues. Around the world, an estimated 10%-15% of adults over 60 have some degree of osteoarthritis. It most commonly affects the joints in the knee, hands, feet, and spine, and is also relatively common in other joints such as the shoulder and hip joints. There are two types of osteoarthritis: primary and secondary. Primary osteoarthritis is a chronic degenerative disease that is related to, but not caused by, aging. As a person ages, the water content of their cartilage decreases, thus weakening it and making it less resilient and more susceptible to degradation. There are strong indications that genetic inheritance is a factor, as up to 60% of all OA cases are thought to result from genetic factors. The main symptoms are pain, loss of ability, and "joint stiffness after exercise or use." These symptoms are often aggravated by activity or rigorous exercise and relieved during rest, though the disease may eventually progress to the point where the patient even feels pain when resting, and some people report pain so intense that it wakes them up when they are sleeping. Osteoarthritis, at present, cannot be cured, and will likely get worse over time, but the symptoms can be controlled. Treatments vary widely, from alternative medicine, to lifestyle changes such as exercise and diet, to physical aids such as canes or braces, to medications such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroids, and more. Osteoarthritis is the most common joint disease of human. Among the elderly knee osteoarthritis is leading cause of chronic disability in developed countries. Some people in India are unable to walk independently from bed and bath-room because of Osteoarthritis of the knee or hip joint. Osteoarthritis (OA) also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion. A variety of causes viz. hereditary, developmental, metabolic, and mechanical may initiate processes leading to loss of cartilage. When bone surfaces are not well protected by cartilage, bone may get exposed and damaged. As a result of decreased movement secondary to pain, atrophy of regional muscles, and ligaments may become more lax. The goal of treatment is to reduce or eliminate the signs and symptoms of Osteoarthritis. Mild to moderate disease is often treated with topical therapies. Sponsor has developed the NGA-01Gel containing the fixed dose combination of alcohol and water mixture, with active herbal ingredients, without preservatives and dyes. The Gel is easy to apply, and the cosmetic appearance is that of a white, milky gel, easily-spreadable that absorbs completely into the skin a few minutes after application and it is expected that the Gel will differentiate from marketed formulations by patient preference for the gel and gel.

Conditions

Arthritis Osteoarthritis

Keywords

osteoarthritis; pain

Outcome Measures

Primary Outcomes (1)

• Change in pain visual analog scale (VAS) scores (0-10) from baseline

  Pain was recorded as per physician's analysis as per SOP, 0 as lowest and 10 as highest

  Day 0 - Day 60

Secondary Outcomes (5)

• Change in WOMAC scores

  Day 0 - Day 60

• Change in Numeric Pain Rating Scale (NPRS) score

  Day 0 - Day 60

• Change in Range of motion (ROM)

  Day 0 - Day 60

• Change in Physician's Global Assessment of Arthritis

  Day 0 - Day 60

• Change in Patient's Global Assessment of Arthritis

  Day 0 - Day 60

Study Arms (2)

NGA-01 gel

ACTIVE COMPARATOR

A formulation with natural ingredients expected to be used for joint pain in Osteoarthritis

Other: NGA-01 gel

Placebo gel

PLACEBO COMPARATOR

Placebo gel with no active ingredient

Other: Placebo

Interventions

NGA-01 gel OTHER

NGA-01 is a gel formulation with mostly herbal active ingredients

NGA-01 gel

Placebo OTHER

A Placebo with no active ingredients

Placebo gel

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects having at least one or more sign and symptoms of Osteoarthritis like Pain in joints (at Knee, Hip, Ankle, Elbow and Shoulder), stiffness, difficulty in flexion and extension, crepitus, swelling etc for more than 3 months prior to the study.
• Pain score of at least 4 cm on a 10-cm linear visual analogue scale.
• Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
• Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
• Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the treatment areas during the treatment period.
• If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
• Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
• Are willing to avoid participation in any other interventional clinical trial for the duration of this study.

You may not qualify if:

• Are pregnant, breast-feeding, or planning to become pregnant during the study.
• Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis, Gouty Arthritis.
• Complications of OA, like Pseudogout, Spontaneous osteonecrosis of the knee, Ruptured Baker cyst, Bursitis, Anserine bursitis (knee)interfere with the disease and treatment.
• Severe Stomach infection.
• Severely traumatised and/or very severe or mucosal inflammation
• Peritonsillar abscess
• Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including Non Steroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
• Any anti-inflammatory drugs intake by systemic route within 12 hours before randomization
• Any paracetamol intake within 6 hours before randomisation
• Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
• Heavy smokers (\>10 cigarettes/day)
• Have open sores or open lesions in the treatment area(s).
• Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of plaque Arthritis.
• Have participated in any interventional clinical trial in the previous 30 days.
• Have a known sensitivity to any of the constituents of the test product

Sponsors & Collaborators

• Nutrin GmbH: lead
• Galaxa Pharma: collaborator
• Mittal Global Clinical Trial Services: collaborator

Study Sites (1)

Moraya Multispeciality Hospital

Pune, Maharashtra, 411033, India

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: double blind, randomized, parallel group study against placebo

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: October 31, 2020
• Primary Completion: January 15, 2022
• Study Completion: January 25, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

IN (1)