LT-NS001 versus Naprosyn® in Knee Osteoarthritis

• Research type

  Research Study

• Full title

  A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Arthritis Non-Inferiority Study of LT-NS001 versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates

• IRAS ID

  40741

• Contact name

  Christopher J Hawkey

• Sponsor organisation

  Logical Therapeutics Inc.

• Eudract number

  2009-018029-57

• Clinicaltrials.gov Identifier

  NCT01063920

• Research summary

  A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, ACTIVE-COMPARATOR, ARTHRITIS NON-INFERIORITY STUDY OF LT-NS001 VERSUS NAPROSYN© FOR TWELVE WEEKS IN OSTEOARTHRITIS PATIENTS TO COMPARE ENDOSCOPIC GASTRIC ULCER RATES Osteoarthritis is a condition that affects the joints, most frequently the knees, hips and small joints of the hands. It is the most common type of arthritis in the UK, with an estimated 8.5 million people affected by the condition. There is no cure for osteoarthritis, but the symptoms can be eased by using a number of different treatments. NSAIDs ('non-steroidal anti-inflammatory drugs') are the most common medications taken worldwide for the treatment of osteoarthritis. Although NSAIDs are proven to relieve the symptoms, they can also break down the lining in the stomach that protects against stomach acid, and this can cause gastrointestinal (GI) side-effects. About 10-20% of patients taking NSAIDs experience an upset stomach or indigestion. The study is being conducted to compare the occurrence of stomach ulcers in two groups of study participants, who are taking two different ??non-steroidal anti-inflammatory drugs? (NSAIDs) for osteoarthritis pain. One of the drugs is already approved for use in patients (Naprosyn©), while the other one is a new treatment (LT-NS001). LT-NS001 can potentially cause less damage to the lining of the stomach. The study will be conducted in about 76 sites in North America and the UK. Approximately 534 patients with ostheoarthritis of the knee are planned to be enrolled in the study. Participants will be randomly assigned to treatment with the study drug or the comparator drug, to be taken orally twice a day for 12 weeks, which will then be followed by 4 weeks follow up.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/22

• Date of REC Opinion

  26 Apr 2010

• REC opinion

  Further Information Favourable Opinion