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

NCT00635063 | Terminated Phase 3

• 1 other identifier: P-AD923-005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain

Keywords

Cancer Breakthrough Pain

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Study Arms (2)

AD 923

EXPERIMENTAL

Drug: AD 923

MSIR

ACTIVE COMPARATOR

Drug: AD 923

Interventions

AD 923 DRUG

AD 923; MSIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sosei: lead

Study Sites (1)

Sosei R&D Ltd

Saffron Walden, Essex, CB10 1XL, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Davies, MBBS

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2008
• Last Updated: June 6, 2008

Record last verified: 2008-06

Locations

GB (1)