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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

NCT ID: NCT00635063

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Pain

Keywords

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Cancer Breakthrough Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AD 923

Group Type EXPERIMENTAL

AD 923

Intervention Type DRUG

MSIR

Group Type ACTIVE_COMPARATOR

AD 923

Intervention Type DRUG

Interventions

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AD 923

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sosei

INDUSTRY

Sponsor Role lead

Responsible Party

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Sosei R&D Ltd

Principal Investigators

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Andrew Davies, MBBS

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Sosei R&D Ltd

Saffron Walden, Essex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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P-AD923-005

Identifier Type: -

Identifier Source: org_study_id