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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00635063
• Other study ID #: P-AD923-005
• Status: Terminated
• Phase: Phase 3
• First received: March 4, 2008
• Last updated: June 5, 2008
• Start date: February 2008

Study information

• Verified date: June 2008
• Source: Sosei
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsRomania: National Medicines AgencySpain: Spanish Agency of MedicinesNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer
• Pain

Intervention

Drug:
• AD 923

Locations

Country	Name	City	State
United Kingdom	Sosei R&D Ltd	Saffron Walden	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Sosei

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.