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

• Conditions: Cancer break-through pain; MedDRA version: 9.1Level: LLTClassification code 10058019Term: Cancer pain

• Registration Number: EUCTR2005-002552-17-DE
• Lead Sponsor: Sosei R&D Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-05
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The subject is a male or female, at least 18 years of age.
Subjects with a malignancy who are receiving, and are tolerant to, opioid therapy for his or her underlying persistent cancer pain. The dose of background opioid therapy must be stable for at least 7 days prior to the screening visit and should not be changed during the study. The minimum dose of background opioid therapy should be 60 mg of morphine or morphine equivalent or 25 µg/hour transdermal fentanyl.
The subject must typically be experiencing 2 to 6 episodes of target breakthrough pain per day that require treatment and be willing and able to use opioid therapy as treatment.
If female, the subject has a negative urine pregnancy test and is not lactating, or has not been of childbearing potential for at least 3 months prior to study drug administration.
The subject is able and willing to understand the study and cooperate with all study instructions.
The subject is able and willing to provide written informed consent.
The subject has a life expectancy of =3 months.
The subject or his or her caregiver has easy, reliable access to a telephone.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 a history of alcohol or substance abuse within the last 2 years.
The subject has hepatic dysfunction as shown by alanine aminotransferase [ALT] and /or aspartate aminotransferase [AST] levels elevated more than 5 times the upper limit of normal.
The subject has renal dysfunction as shown by creatinine elevated more than 1.5 times the upper limit of normal.
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 uncontrolled infection.
The subject has received treatment with an investigational drug or has participated in a clinical study within 4 weeks of the screening visit.
The subject has had treatment with radiotherapy to a painful site within 14 days prior to study entry or has had any therapy that could alter pain or response to pain medication.
The subject is taking intrathecal or epidural forms of opioids.
The subject is taking any prohibited medications as described in the concomitant medications section (Section 6.3).
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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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.;Primary end point(s): The primary endpoint is the sum of pain intensity difference (SPID) from 0 to 30 minutes.