A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis

Change in Hip Pain as Assessed by VAS

Assessment of change from baseline in target hip pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.

Hip Disability and Osteoarthritis Outcome Score (HOOS)

The HOOS questionnaire was built upon the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC®). Questions from the WOMAC® were used as the basis for the survey, and 2 dimensions were added: sport and recreation and hip-related quality of life. The HOOS is composed of 40 questions in 5 subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items), and Hip-Related Quality of Life (4 items). A total score, ranging from 0 to 100 is calculated. Higher scores represent better functioning.

Timed Up and Go Test (TUG)

The TUG test is used to determine the time needed to progress from sitting to standing and walking. In addition, the test helps to evaluate the probability for falls. The individual starts in a seated position in a chair with armrests and, upon command, stands up, walks 3 meters, turns around, walks back to the chair, and sits down. The time stops when the subject is seated. The use of walking aids should be recorded and kept consistent between tests.

UCLA Activity Score

The UCLA Activity Score includes 10 statements that cover the range of activity states from being "wholly inactive, dependent on others, and cannot leave residence" to "regularly participate in impact sports." The respondents are instructed to select one statement that is most representative of their current activity. Lower scores on the scale reflect a low level of activity and higher scores reflect more activity.

Joint Space Width (JSW) on standing X-ray

To evaluate the effects of 2 dose levels of TG-C on the structural features of the hip joint

Physical Component Score (PCS) of the Short Form 12-Item Health Survey (SF-12 Questionnaire)

Evaluation the Health-Related Quality of Life (HRQoL) as measured by the physical component score (PCS) of the 12-Item Short-Form Health Survey version 2 (SF-12v2®) questionnaire addresses physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. The mean score is set to 50. Scores \>50 indicate better physical or mental health than the mean, and scores \<50 indicate worse physical or mental health than the mean.

Clinician Global Impression of Change (CGI-C)

The CGI-C asks clinicians to choose the response that best describes the overall change in the patient's OA since they received the study medication as "much better," "moderately better," "a little better," "no change," "a little worse," "moderately worse," or" much worse." Clinicians are also asked to indicate if the change that the patient has experienced is clinically meaningful.

Clinician Global Impression of Severity (CGI-S)

clinician to choose the response that best describes the severity of the patient's overall OA as "none," "mild," "moderate," or "severe."

Patient Global Impression of Severity (PGI-S)

patients to select the response that best describes the severity of their OA, their OA-related pain, and their OA-related stiffness and their difficulty with activities as a result of their OA as "none," "mild," "moderate," or "severe."