NCT00594516

Brief Summary

The objective of this study is to test the idea that the immediate-release (IR) form of tapentadol (CG5503) can be directly converted into an approximately equivalent total daily dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and efficacy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at below P25 for phase_3 low-back-pain

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3 low-back-pain

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, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 26, 2010

Completed
Last Updated

April 15, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

January 3, 2008

Results QC Date

April 28, 2009

Last Update Submit

March 26, 2015

Conditions

Low Back Pain

Keywords

Low Back PainDose EquivalenceTapentadol (CG5503)Tapentadol-IRTapentadol-ER

Outcome Measures

Primary Outcomes (1)

  • The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)

    For this twice daily pain assessment, the subjects were to indicate the level of average 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".

    14 days for each cross-over period

Secondary Outcomes (4)

  • The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment

    14 days for each cross-over period

  • The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment

    14 days for each cross-over period

  • Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period

    14-day for each DB treatment period

  • Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.

    14 days for each treatment period

Study Arms (2)

001

EXPERIMENTAL

tapentadol (CG5503) Immediate Release (IR) Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100 150 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second,tapentadol (CG5503) Immediate Release IR 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period

Drug: tapentadol (CG5503) Immediate Release IRDrug: tapentadol (CG5503) Immediate Release (IR)

002

EXPERIMENTAL

tapentadol (CG5503) Extended Release (ER) During 2 double blind periods: Tapentadol ER 100 150 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second

Drug: tapentadol (CG5503) Extended Release (ER)

Interventions

tapentadol (CG5503) Immediate Release (IR)DRUG

Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second

001
tapentadol (CG5503) Extended Release (ER)DRUG

During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second

002

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Low Back Pain (LBP) of non-malignant origin present for at least 3 months immediately before study entry
  • Taking drug treatment for pain for at least 3 months before screening and who are dissatisfied with current therapy
  • Subjects receiving opioid treatment must have a total daily opioid dose \<= 160 mg/day of oral morphine equivalent
  • For entry into open label period patients must have a baseline score \>=5 on an 11-point NRS, calculated as the average pain intensity during the last 3 days of the washout period
  • For entry into the double-blind period subjects must have remained on the same optimal stable dose and frequency of tapentadol (CG5503) IR administration during the last 3 days of the open-label treatment period

You may not qualify if:

  • Presence of conditions other than Low Back Pain (LBP) that could make it hard to assess or self-evaluate pain
  • Surgery in low back area within 3 months of screening or expected surgery in the low back area during the study
  • Any scheduled surgery or painful procedure during the study, or any clinically significant disease that, in the opinion of the investigator, may affect efficacy or safety assessments
  • History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated and is no longer present
  • Women who are pregnant or breast-feeding
  • Moderately or severely impaired liver function
  • Severely impaired kidney function
  • History of chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C in past 3 months
  • History of seizure disorder
  • Alcohol or drug abuse
  • Uncontrolled high blood pressure
  • Clinically relevant history of hypersensitivity, allergy, or contraindications to acetaminophen or opioid analgesics (or ingredients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Etropolski MS, Okamoto A, Shapiro DY, Rauschkolb C. Dose conversion between tapentadol immediate and extended release for low back pain. Pain Physician. 2010 Jan-Feb;13(1):61-70.

    PMID: 20119464DERIVED

MeSH Terms

Conditions

Low Back 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
Mila Etropolski, MD Clinical Leader
Organization
Johnson & Johnson Pharmaceutical Research & Development
metropol@its.jnj.com
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
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

April 15, 2015

Results First Posted

July 26, 2010

Record last verified: 2015-03