A Study Evaluating the Safety and Efficacy of a Second Course of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees

NCT02837900 | Completed Phase 2

• 1 other identifier: TPX-100-2
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 administered by intra-articular injection to subjects with osteoarthritis of the knee who participated in study TPX-100-1.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 who participated in study TPX-100-1

  Safety, Tolerability and primary efficacy

  Follow subjects for 6 months

Secondary Outcomes (1)

• Change in patellar cartilage thickness in each knee as measured on standardized MRI from baseline to 6 months.

  Follow subjects for 6 months

Study Arms (3)

Previous LT TX knee and right placebo

PLACEBO COMPARATOR

Previous left treated knee will have placebo treatment in this protocol.

Drug: TPX-100 200 mg 4 times weekly for 4 weeks

Previous RT TX knee and left placebo

PLACEBO COMPARATOR

Previous right treated knee will have placebo treatment in this protocol.

Drug: TPX-100 200 mg 4 times weekly for 4 weeks

Both TX with Active

ACTIVE COMPARATOR

Both knees with receive Active

Drug: TPX-100 200 mg 4 times weekly for 4 weeks

Interventions

TPX-100 200 mg 4 times weekly for 4 weeks DRUG

Ea. subject will received active TPX-100 200mg in the Left knee

Also known as: TPX-100 100mg Left

Both TX with Active; Previous LT TX knee and right placebo; Previous RT TX knee and left placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous enrollment in study TPX-100-1
• Cruciate and collateral ligament stability as defined by clinical examination
• Able to read, understand, sign and date the subject informed consent
• Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication during the injection period and through study day 30. The maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg per day).
• Willingness to use only hydrocodone or hydrocodone/acetaminophen (e.g. Norco) for breakthrough pain through study day 30.
• Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen through study day 30.
• Female subjects of child bearing potential who are sexually active (non-abstinent) must agree to and comply with using 2 highly effective methods of birth control (oral contraceptive, implant, injectable or indwelling intrauterine device, condom with spermicide, or sexual abstinence) while participating in the study.

You may not qualify if:

• "Possibly, probably or definitely" drug-related SAEs in TPX-100-1; severe or ongoing "possibly, probably or definitely" related AEs in TPX-100-1.
• Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight \> 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
• Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
• Joint replacement or any other knee surgery planned in the next 12 months
• History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
• Knee effusion \> 2+ on the following clinical scale:
• Zero = No wave produced on downstroke
• Trace = Small wave on medial side with downstroke
• + = Larger bulge on medial side with downstroke
• + = Effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
• + = So much fluid that it is not possible to move the effusion out of the medial aspect of the knee screening
• Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee \< 3 months before screening
• Last intra-articular knee injection of corticosteroids \< 2 months before screening
• Use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
• Known hypersensitivity to TPX-100

Sponsors & Collaborators

• OrthoTrophix, Inc: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 20, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09