Open-Label Extension to Evaluate the Long-Term Safety, To... | NCT00904280

Studies
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

NCT00904280

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Status

Completed

Last Update Posted

May 19, 2009Estimated

Enrollment

239Actual

Phase

Phase 3

Conditions

Cancers, Pain
Lower Back Pain

Interventions

Oxymorphone ER

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

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

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Jul 2003Actual

Completion Date

Jul 2003Actual

First Submitted Date

May 15, 2009

First Submission Date that Met QC Criteria

May 18, 2009

First Posted Date

May 19, 2009Estimated

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 18, 2009

Last Update Posted Date

May 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.

Detailed Description

Not provided

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

239Actual

Label	Type	Description	Intervention Names
Oxymorphone ER	Experimental		Drug: Oxymorphone ER

Name	Type	Description	Arm Group Labels	Other Names
Oxymorphone ER	Drug	Open label	Oxymorphone ER

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER		1 year study

Secondary Outcomes

Measure	Description	Time Frame
To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain		1 year study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies.
Males or females, age 18 and 75 years, inclusively.
The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential.

Exclusion Criteria:

The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019.
The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy.
Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sr. Director	Endo USA Inc., a Keenova Therapeutics Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Clinical Research Center		Tucson	Arizona		United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010146	Pain
D017116	Low Back Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain

Browse Leaves

Not provided

Browse Branches

Not provided