NCT00263575

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

November 19, 2020

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

December 7, 2005

Results QC Date

January 23, 2014

Last Update Submit

June 14, 2024

Conditions

PainCancer

Keywords

EN3267Breakthrough PainSafety StudyFentanyl Tablets

Outcome Measures

Primary Outcomes (1)

  • Evaluate the Long-term Safety and Effectiveness of EN3267

    screening, 2 week titration period and 12 monthly study visits

Study Arms (1)

sublingual fentanyl tablet

EXPERIMENTAL
Drug: EN3267

Interventions

EN3267DRUG

EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Also known as: Fentanyl
sublingual fentanyl tablet

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 17 years of age or older.
  • Stable cancer-related pain.
  • Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain.
  • Experiencing 1-4 episodes of breakthrough pain per day.
  • Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.

You may not qualify if:

  • Have previously been exposed to EN3267.
  • Are pregnant or lactating.
  • Have uncontrolled or rapidly escalating pain.
  • Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
  • Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.
  • Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.
  • Are scheduled to receive an investigational drug other than EN3267 during the course of the study.
  • Have hypersensitivity, allergy or contraindication to fentanyl.
  • Have significant prior history of substance abuse or alcohol abuse.
  • Would have difficulty complying with the protocol, as assessed by the investigator.
  • Are unable to read, write, or comprehend the English language in order to complete diaries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Pain Institute

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (1)

  • Nalamachu S, Hassman D, Wallace MS, Dumble S, Derrick R, Howell J. Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Curr Med Res Opin. 2011 Mar;27(3):519-30. doi: 10.1185/03007995.2010.545380. Epub 2011 Jan 6.

    PMID: 21208151DERIVED

MeSH Terms

Conditions

PainNeoplasmsBreakthrough Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Fiona Miller
Organization
Strakan Pharmaceuticals Ltd
fiona.miller@prostrakan.com
01896 66868

Study Officials

  • Julian Howell

    Kyowa Kirin Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 9, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

June 18, 2024

Results First Posted

November 19, 2020

Record last verified: 2024-06

Locations

US(1)