NCT00449176

Brief Summary

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
981

participants targeted

Target at P75+ for phase_3 low-back-pain

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 24, 2010

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

March 16, 2007

Results QC Date

April 17, 2009

Last Update Submit

April 26, 2012

Conditions

Low Back Pain

Keywords

Low Back PainChronic PainPain AssessmentTapentadol

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.

    For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Baseline and 12 weeks

Secondary Outcomes (6)

  • Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.

    Baseline and 12 week endpoint

  • Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.

    Baseline and 12 week endpoint

  • Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12

    Baseline and 12 week endpoint

  • Number of Participants With Treatment Discontinuation Due to Lack of Efficacy

    Baseline and 12 weeks

  • Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12

    Baseline and 12 week endpoint

  • +1 more secondary outcomes

Study Arms (3)

001

EXPERIMENTAL

tapentadol (CG5503) ER 50 100 150 200 250 mg twice daily for 15 weeks

Drug: tapentadol (CG5503) ER

002

ACTIVE COMPARATOR

oxycodone CR 10 20 30 40 50 mg twice daily for 15 weeks

Drug: oxycodone CR

003

PLACEBO COMPARATOR

placebo matching placebo twice daily for 15 weeks

Drug: placebo

Interventions

tapentadol (CG5503) ERDRUG

50, 100, 150, 200, 250 mg twice daily for 15 weeks

001
oxycodone CRDRUG

10, 20, 30, 40, 50 mg twice daily for 15 weeks

002
placeboDRUG

matching placebo twice daily for 15 weeks

003

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and non-pregnant, non-lactating women having a diagnosis of Lower Back Pain (LBP) of non-malignant origin present for at least 3 months
  • Patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
  • Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to \< 160 mg of oral morphine
  • Baseline score of =5 on an 11-point numerical rater scale, calculated as the average pain intensity during the last 3 days prior to randomization.

You may not qualify if:

  • History of alcohol and/or drug abuse in Investigator's judgement
  • History of significant liver insufficiency
  • chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
  • Life-long history of seizure disorder or epilepsy
  • History of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
  • Uncontrolled hypertension
  • Patients with severely impaired renal function
  • Patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.

    PMID: 24985410DERIVED

  • Biondi DM, Xiang J, Etropolski M, Moskovitz B. Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis. Clin Drug Investig. 2014 Aug;34(8):565-76. doi: 10.1007/s40261-014-0209-y.

    PMID: 24916058DERIVED

  • Etropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177.

    PMID: 24353047DERIVED

  • Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J Opioid Manag. 2013 Jan-Feb;9(1):51-61. doi: 10.5055/jom.2013.0147.

    PMID: 23709304DERIVED

  • Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.

    PMID: 23340531DERIVED

Related Links

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Senior Director, Clinical Leader
Organization
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
609-730-4537

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 16, 2007

First Posted

March 20, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 30, 2012

Results First Posted

June 24, 2010

Record last verified: 2012-04