Status:
TERMINATED
A Multicentre Study to Evaluate the Safety and Efficacy of AD 923 in Comparison to MSIR for the Treatment of CBP in Subjects
Lead Sponsor:
Sosei
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00635063
Start Date
February 1 2008
Last Update
June 6 2008
Active Locations (1)
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1
Sosei R&D Ltd
Saffron Walden, Essex, United Kingdom, CB10 1XL