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

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ClinicalTrials.gov Identifier: NCT00635063
Recruitment Status : Terminated (Termination is due to a combination of a device defect potentially impacting the quality of the AD 923 IMP and a major change in corporate strategy.)
First Posted : March 13, 2008
Last Update Posted : June 6, 2008
Sponsor:
Information provided by:

Study Description
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 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.


Condition or disease Intervention/treatment Phase
Cancer Pain Drug: AD 923 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: AD 923 Drug: AD 923
Active Comparator: MSIR Drug: AD 923


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.

Secondary Outcome Measures :
  1. To assess the safety and tolerability of AD 923 in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635063


Locations
United Kingdom
Sosei R&D Ltd
Saffron Walden, Essex, United Kingdom, CB10 1XL
Sponsors and Collaborators
Sosei
Investigators
Principal Investigator: Andrew Davies, MBBS Royal Marsden NHS Foundation Trust
More Information

Responsible Party: Dr Robin Bannister, Sosei R&D Ltd
ClinicalTrials.gov Identifier: NCT00635063     History of Changes
Other Study ID Numbers: P-AD923-005
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008

Keywords provided by Sosei:
Cancer Breakthrough Pain

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms