A Multicentre Study to Evaluate the Safety and Efficacy of AD 923 in Comparison to MSIR for the Treatment of CBP in Subjects
A Multicentre Study to Evaluate the Safety and Efficacy of AD 923 in Comparison to MSIR for the Treatment of CBP in Subjects
Purpose:

 The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely
 used current treatment (MSIR) in the management of target BTP in subjects with malignancies
 who are taking a stable dose of background opioids. The efficacy evaluation criteria have
 been designed to determine whether AD 923 provides superior analgesia compared with MSIR as
 measured by the primary endpoint.
Main Inclusion Criteria:

 -  The subject is a male or female, at least 18 years of age.

 -  The subject has a malignancy, is receiving opioid therapy for his or her underlying
 persistent cancer pain, and is tolerant to the opioid therapy.

 -  The subject typically has 2 to 6 episodes of target BTP per day that require
 treatment.

 -  The subject has a life expectancy of >3 months.

 -  The subject or his or her caregiver has easy, reliable access to a telephone.

 Main Exclusion Criteria:

 -  The subject is a female who is pregnant or lactating.

 -  The subject has any respiratory or cardiac condition that, in the opinion of the
 investigator, may be clinically worsened by opioids.

 -  The subject has any allergy to the AD 923 product or excipients, namely: fentanyl,
 dehydrated alcohol, menthol, saccharin, and citrate buffer; or to the MSIR product
 excipients, namely: morphine sulphate, lactose (anhydrous), pregelatinized maize
 starch, povidone, purified water, magnesium stearate, talc, and tablet coatings.

 -  The subject has any neurological or psychiatric disease that, in the opinion of the
 investigator, would compromise data collection.

 -  The subject has uncontrolled or rapidly escalating pain.

 -  The subject has any significant laboratory test results that, in the opinion of the
 investigator, will compromise subject safety or the conduct of the study.

 -  The subject has plans to undergo chemotherapy, radiotherapy, or surgery during the
 treatment period. The exception is that subjects may continue chemotherapy over the
 study period, provided it is not expected to alter the pain state or response to pain
 medication.