OrthoTrophix’ Intra-Patient Randomization Design Supported by Advanced Cold-Chain Packaging

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Osteoarthritis affects around 30 million Americans, causing pain and severe disability. Unfortunately, there are few treatments. Many rely on over-the-counter analgesics to manage their pain. Some ultimately opt for joint replacement surgery.

To better help patients, OrthoTrophix is developing a peptide drug designed to regenerate cartilage. The company hopes this approach will restore function.

Novel Drug and Trial Design Generate Unique Clinical Supply Management Challenges

OrthoTrophix began a two-part, phase 2 clinical trial in February 2014. The first part tested the drug’s safety and efficacy in 27 patients with mild to moderate osteoarthritis in both knees. In addition to safety, the study looked at whether the peptide drug reduced pain and improved function.

Because individual arthritis patients experience pain and loss of function differently, the company designed their study to eliminate this subjectivity. The solution was a randomized, double-blind, intra-patient, placebocontrolled trial. In other words, participants received the drug in one knee and the placebo in the other.

But by solving the patient subjectivity challenge, OrthoTrophix created a more complex injection schedule, which required advanced clinical supply logistics. Each trial participant received four rounds of injections, one week apart, in both knees. Some patients received the drug in the right knee and a placebo in the left; and some received the drug in the left knee and placebo in the right.

Because the agents were delivered in four cycles, OrthoTrophix needed packaging that ensured drug and placebo always went into the correct knees without compromising the double-blind.

Sherpa helped OrthoTrophix solve the right knee/left knee issue by creating an efficient, easy-to-use package. Each kit had two vials, with four kits to each box – enough for a single patient throughout the trial.

All vials were labeled with an R or an L (for right knee/left knee) to make their destinations abundantly clear to physicians at the clinical sites. R vials were color-coded red, while L vials were color-coded lavender to reduce the possibility of user error. All kits were randomly serialized, and each vial in a kit was labeled with a matching serial number. On-demand delivery added another layer of complexity.