A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects With Malignancies
- 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
- 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