An open-label study investigating long-term safety and tolearability of Nasalfent (Fentanyl Citrate Nasal Spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid therapy

• Conditions: The treatment of Breakthrough Cancer Pain (BTCP) in subjects taking regular opioid therapy.; MedDRA version: 8.1Level: LLTClassification code 10058019Term: Cancer pain

• Registration Number: EUCTR2006-005403-34-FR
• Lead Sponsor: Archimedes Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria Subjects will be included in the study if they meet all of the following criteria: 1. EITHER The subject was previously enrolled in Studies CP043/06/FCNS or CP044/06/FCNS and: a. Successfully completed the study (including the return of any remaining drug supplies and successful completion of the subject diaries). b. Continues to experience episodes of breakthrough pain that were adequately controlled with a designated dose of Nasalfent in Studies CP043/06/FCNS or CP044/06/FCNS. c. The subject’s medical condition is such that the subject continues to meet the other inclusion/exclusion criteria listed below. OR The subject has not participated in Studies CP043/06/FCNS or CP044/06/FCNS and wishes to participate in this study (CP045/06/FCNS). 2. Subjects who are able and willing to provide written informed consent. 3. Male or female subjects, 18 years of age and older. 4. If female, and of childbearing potential (not surgically sterile or =1 year after the onset of amenorrhea due to menopause), must (a) have a negative serum pregnancy test, (b) not be lactating, and (c) agree to practice a reliable form of contraception or abstinence during the study. 5. Subjects who have a histologically documented diagnosis of a malignant solid tumor or a hematological malignancy causing cancer-related pain. 6. Subjects who are taking at least 60 mg oral morphine or equivalent for at least 1 week for cancer-related pain as regular, 24-hour medication for their underlying persistent cancer pain. 7. Subjects who are experiencing, on average, but not necessarily every day, 1 to 4 episodes of BTCP per day that are adequately controlled with a stable dose of standard rescue medication, typically a fast-acting opioid, of which the subject should have an adequate supply throughout the study. Breakthrough pain is defined as a transitory flare of moderate to severe pain (on a 4 point scale from 0 to 3 [none, mild, moderate, severe] as defined by the Breakthrough Pain Questionnaire in Section 15.2) that occurs on a background of persistent pain controlled to moderate intensity or less by the opioid regimen. If the subject has more than 1 type of breakthrough pain, or has breakthrough pain in more than 1 location, only 1 of the pains will be identified as a target” breakthrough pain. 8. Subjects who, in the opinion of the investigator, are willing and able (personally or with the help of a caregiver) to a. Evaluate and record pain intensity and pain relief. b. Assess medication performance at specific times after dosing. c. Record AEs. d. Record each instance of the use of study drug and standard rescue medication in a subject diary for the duration of the study. 9. Subjects with an Eastern Cooperative Oncology Group (ECOG) score of =2 and a life expectancy which, in the opinion of the investigator, will allow them to participate for the duration of the study.
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

Exclusion Criteria Subjects may be excluded from participating in the study if they meet any of the following criteria: 1. Subjects with an opioid or fentanyl intolerance. 2. Subjects with uncontrolled or rapidly escalating pain. 3. Subjects using intrathecal or epidural opioids. 4. Subjects whose condition is unstable or rapidly deteriorating, such that they are (in the opinion of the investigator) unlikely to be able to make an effective contribution to the study. 5. Subjects with sleep apnea or active brain metastases with increased intracranial pressures. 6. Subjects with any respiratory or cardiac condition that, in the opinion of the investigator, may be worsened by opioids. 7. Subjects with any other medical condition that, in the judgment of the investigator, would confound the objectives of the study. 8. Subjects with a recent history of alcohol or substance abuse that would compromise data collection. 9. Subjects with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection. 10. Subjects with clinically significant renal and hepatic dysfunction test results at Screening outside the following limits: a. Serum creatinine must be =2.0 mg/dL, or creatinine clearance calculated by Cockcroft-Gault formula must be =50 mL/min. b. Serum total bilirubin must be =2.0 mg/dL. c. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase must be =3 times the upper limit of normal (=5 times the upper limit of normal if due to liver metastases). 11. Subjects taking any medication likely to affect the physiology of the nasal mucosa. 12. Any abnormal nasal physiology and/or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished. 13. Subjects with known intolerance to nasal sprays and/or pharmaceutical materials found in the investigational products. 14. Subjects taking monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit or with an anticipated need for MAOIs during the study. 15. Subjects with uncontrolled infection. 16. Subjects who have received treatment with an investigational drug (other than those in Studies CP043/06/FCNS and CP044/06/FCNS) within 4 weeks of the screening visit. 17. Subjects whose primary source of breakthrough pain is not cancer related.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the long-term safety, tolerability, and acceptability of Nasalfent in the treatment of BTCP.;Secondary Objective: ;Primary end point(s): Adverse events. Objective nasal examination. Subjective nasal assessment. Withdrawal due to AEs. Physical examination, including vital signs. Laboratory assessments. Subject acceptability assessments.