A clinical trial to study the effects of Diclofenac in Lipogel in Comparison to Emulgel and Placebo in Patients with Signs and Symptoms of Osteoarthritis of the Hip, Knees and Hands.

Phase 2

Completed

Conditions: Osteoarthritis of the Hip, Knees and/or Hands

Registration Number: CTRI/2012/12/003263

Lead Sponsor: University Institute of Pharmaceutical Sciences

Brief Summary: This study is a single centric randomized, double-blind trial for evaluation of the safety and efficacy of a novel gel formulation of Diclofenac 1% w/w in patients with signs and symptoms of osteoarthritis of the knees. Thirty six patients with knee osteoarthritis were treated (randomized) with 1% w/w diclofenac topical novel gel or marketed gel or placebo gel (negative control), for a period of 6-weeks (evaluations were done on 1, 2, 4 & 6 week). Efficacy outcome measure selected was the change from baseline to end of study on the WOMAC (i.e., Westren Ontario and McMaster Universities) OA index of pain, stiffness and physical function having scores on 5-point Likert scale. Other safety and efficacy measures selected were change in swelling, adverse effect, dermal-irritation scores, changes in vital signs of the patient obtained at each visit. In the current clinical study, patients of all the groups, showed a positive response to the novel topical formulations of Diclofenac vis-Ã -vis placebo at the end of treatment. Diclofenac novel gel 1%w/w, however, was found to be more effective in comparison to marketed formulation of diclofenac at equivalent drug concentration. With respect to safety, all the tested formulations were found to be safe, as no dermal as well as GI adverse event was recorded during study. The results of phamacodynamic along with other safety evaluation protocols followed in the current investigations clearly indicated the superiority of the novel gel formulation of diclofenac.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

1.Male or female of age â‰¥ 18. 2.Must be in generally good health as confirmed by medical and previous medication history, and baseline physical examination including vital signs. 3.Symptomatic OA of the target hip or knee joint as evidenced by hip or knee pain for at least 3 months (for at least 20 days of each month) and osteophytes confirmed by an x-ray taken within the last two years 4.After a full explanation of the study, subjects must understand the nature of the study and sign the informed consent form to participate. 5.Patients must have osteoarthritis of knees, hip and hands for a minimum of six months.
have moderate pain in the most involved area when not taking non-steroidal anti-inflammatory drugs (NSAIDs). 6.Demonstrated x-ray evidence of osteoarthritis in the most involved areas during the last six months 7. Patient who also met two of the following three clinical criteria: a)Morning stiffness of, 30 minutes duration, crepitus on motion. b)Rating their pain in the index knee as >3 on a five-point Likert scale. c)Taking oral NSAIDs at least 3 days per week for the past 3 months or for >25 of the past 30 days. 8. Patients had to meet three osteoarthritis flare criteria: a)Pain in the index knee on walking >40 mm on a visual analogue scale (VAS). b)Increased by >15 mm compared with pain on pre-study treatment (screening). c)Patient global assessment (PGA) score for osteoarthritis of 3â€“5 and at least one grade increase from screening.

Exclusion Criteria

1.Patient receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to NSAID.
2.Pregnant or lactating females 3.Open wounds, infected skin or fractures 4.Opioid use within 7 days 5.Prior topical medication applied to the painful region/area of study 6.Subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery, etc.).
7.Subjects who are experiencing another type of continuous pain that is more severe in intensity in comparison with the OA target joint pain (e.g. low back pain, fibromyalgia, ankylosing spondylitis, etc.).
8.Subjects with a significant psychiatric disorder (including major depression) or subjects receiving anti-psychotic medication.
9.Subjects who have taken sedatives, hypnotics, phenothiazines, anticonvulsants, tranquilizers or muscle relaxants two weeks preceeding study entry.
These medications cannot be started during the study.
10.Subjects with documented or suspected history of alcohol or drug abuse, or who have a documented or suspected history of an addictive personality.
11.Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean fall in five point scale of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index from the baseline	0, 1, 2, 4, 6 week

Secondary Outcome Measures

Name	Time	Method
Mean fall in five point scale of Patient Global Assessment from the baseline	0, 1, 2, 4, 6 week

Trial Locations

Locations (1): New OPD, Department of Orthopedic Surgery, PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
New OPD, Department of Orthopedic Surgery, PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Dr Vijay G Goni
Principal investigator
1722756747
vijaygoni@gmail.com