Treatment of Breakthrough Pain in Opioid Tolerant Cancer... | NCT00105287 | Trialant

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Treatment of Breakthrough Pain in Opioid Tolerant Cancer... | NCT00105287 | Trialant

Studies
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

NCT00105287

Sponsor

Cephalon

Status

Completed

Last Update Posted

May 9, 2014Estimated

Enrollment

100

Phase

Phase 3

Conditions

Pain
Cancer

Interventions

OraVescent fentanyl (OVF)

Countries

United States

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

NCT00105287

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

C25608/3039/BP/US

Secondary IDs

Not provided

Brief Title

Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Official Title

Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Acronym

Not provided

Organization

Teva Branded Pharmaceutical Products R&D, Inc.INDUSTRY

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jan 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2007Actual

First Submitted Date

Mar 11, 2005

First Submission Date that Met QC Criteria

Mar 11, 2005

First Posted Date

Mar 14, 2005Estimated

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

May 8, 2014

Last Update Posted Date

May 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

CephalonINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.

Detailed Description

Not provided

Conditions Module

Conditions

Pain
Cancer

Keywords

cancer
pain
Breakthrough Pain in cancer patients

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

100

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OraVescent fentanyl (OVF)	Drug

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
Currently taking around the clock opioid therapy for pain
Experience on average, 1-4 breakthrough pain episodes per day

Exclusion Criteria:

Opioid or fentanyl intolerance
Sleep apnea or active brain metastases with increased intracranial pressure
COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cullman Oncology and Hematology		Cullman	Alabama	35058	United States
Advanced Clinical Research Institute

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Non-Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Anaheim

California

92801

United States

Pacific Cancer Medical Center

Anaheim

California

92801

United States

Compassionate Cancer Care Medical Group

Corona

California

92882

United States

Compassionate Cancer Center

Fountain Valley

California

92708

United States

Clinical Trials & Research Associates, Inc.

Montebello

California

90640

United States

San Diego Hospice & Palliative Care

San Diego

California

92103

United States

Pacific Clinical Research

Santa Monica

California

90404

United States

Lovelace Scientific Resources

Miami

Florida

33143

United States

Gulf Coast Pain Specialists

Pensacola

Florida

32503

United States

Hematology Oncology Associates of Treasure Coast

Port Saint Lucie

Florida

34952

United States

Center for Prospective Outcome

Marietta

Georgia

30060

United States

Iowa Pain Management Clinic, PC

Des Moines

Iowa

50265

United States

Donald Berdeaux

Great Falls

Montana

59405

United States

Great Falls Clinic, LLP

Great Falls

Montana

59405

United States

Southern Nevada Cancer Research

Las Vegas

Nevada

89106

United States

NYU Pain Management Center

New York

New York

10016

United States

Research Across America

New York

New York

10021

United States

Brody School of Medicine

Greenville

North Carolina

27858

United States

Gabrail Cancer Center

Canton

Ohio

44718

United States

Lehigh Valley Hospital

Allentown

Pennsylvania

18103

United States

University of Pennsylvania

Philadelphia

Pennsylvania

19104

United States

Charleston Hematology Oncology, PA

Charleston

South Carolina

29403

United States

University of Rochester

San Antonio

Texas

78229

United States

Lifetree Clinical Research

Salt Lake City

Utah

84106

United States

Cache Valley Cancer Treatment and Research Clinic, Inc.

West Point

Utah

84015

United States

ID	Term
D010146	Pain
D009369	Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

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