A Multicentre Study to Evaluate the Safety and Efficacy o... | NCT00635063

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

NCT00635063

Sponsor

Sosei

Status

Terminated

Last Update Posted

Jun 6, 2008Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Cancer
Pain

Interventions

AD 923

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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.

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 4, 2008

First Submission Date that Met QC Criteria

Mar 12, 2008

First Posted Date

Mar 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2008

Last Update Posted Date

Jun 6, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
AD 923	Experimental		Drug: AD 923
MSIR	Active Comparator		Drug: AD 923

Name	Type	Description	Arm Group Labels	Other Names
AD 923	Drug		AD 923 MSIR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009369	Neoplasms
D010146	Pain