Trials Sponsors Conditions Drugs Pricing

Conditions

Pain Chronic Back Pain Chronic Low Back Pain Osteoarthritis Pain In The Hip or Knee

Keywords

Chronic Low Back PainOsteoarthritis Pain In The Hip or KneeOxycodoneMorphine, HydrocodoneTapentadolNUCYNTA ER

Outcome Measures

Primary Outcomes (1)

Change in pain intensity from baseline to end of study as measured on an 11-point numeric rating scale (NRS)
The pain intensity NRS is a commonly used pain scale that is a core recommended outcome measure for chronic pain studies. A score of 0 indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine." Change in pain intensity is measured from baseline to the end of treatment.
Day 1 and Day 29

Secondary Outcomes (6)

11-point pain intensity numeric rating scale (NRS) (twice daily) and diary compliance
Day 1, Day 8, Day 15, Day 22, Day 29
Quality of life as measured by the SF-12v2® Health Survey
Day 8, Day 15, Day 22, Day 29

Study Arms (1)

Nucynta ER

EXPERIMENTAL

Nucynta ER will be 100 to 250 mg every 12 hours

Drug: Nucynta ER

Interventions

Nucynta ERDrug

100 to 250 mg every 12 hours

Also known as: Nucynta Extended Release

Nucynta ER

Eligibility Criteria

Age18 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have a clinical diagnosis of knee or hip osteoarthritis (OA) with history of pain at the reference joint or clinical diagnosis of low back pain (LBP) of non malignant origin for at least 3 months before the screening visit; Be taking hydrocodone, oxycodone CR, or morphine SR for the treatment of chronic LBP, or OA of the knee or hip for at least 2 weeks before the screening visit; Have a baseline pain intensity score of ≥4 on an 11-point pain intensity numeric rating scale; Be willing and able to independently communicate pain characteristics, complete all protocol required measurements/assessments without assistance, understand and complete self-administered questionnaires and adhere to the prohibitions and restrictions specified in this protocol.

Sponsors & Collaborators

Janssen Scientific Affairs, LLC
Industrylead

Study Sites (7)

Jacksonville, Florida, United States

Prairie Village, Kansas, United States

Mandeville, Louisiana, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Oklahoma City, Oklahoma, United States

Clinton, Utah, United States

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

August 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Nucynta ER

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Nucynta ER

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations