Low Back PainPhase 3NCT00594516

Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

A Phase 3 study testing tapentadol (CG5503) Immediate Release IR, tapentadol (CG5503) Extended Release (ER) and tapentadol (CG5503) Immediate Release (IR) in people with Low Back Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: tapentadol (CG5503) Immediate Release IR, tapentadol (CG5503) Extended Release (ER) and tapentadol (CG5503) Immediate Release (IR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: No sites listed yet
Study dates: Dec 2007to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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)

About this study

Official title: A Randomized, Double-Blind, 2-Period, Crossover Study to Establish the Dose Equivalence and Direct Conversion Between Immediate Release (IR) and Extended-Release (ER) CG5503 in Subjects With Moderate-to-Severe, Chronic Low Back Pain

Read the detailed description

This study will establish the dose equivalence and the safety and effectiveness of the Immediate Release (IR) and Extended Release (ER) forms of tapentadol (CG5503) to support the conversion from IR to ER, and ER to IR use. Dose equivalence will be examined in patients diagnosed with moderate-to-severe, chronic Low Back Pain (LBP) requiring drug treatment for at least 3 months, and who are dissatisfied with current therapy. The study consists of 5 periods: a screening period during which patients are evaluated for study eligibility; a 21-day open-label period to find the best, stable dose of tapentadol (CG5503) IR for each patient individually; a 14-day double-blind period when patients are randomly chosen either to continue for 14 days on the stable IR dose from the open-label period or switch to the ER form; a second, 14-day period during which patients switch to whichever form of tapentadol (CG5503) they did not take during the first 14-day period (the total daily dose [TDD] remains approximately equivalent for the IR and ER forms throughout both double-blind periods); and a follow-up period. During the study, pain levels will be recorded and overall safety measures taken. The expectation (thought) is that approximately equivalent doses of both forms of tapentadol (CG5503) provide equivalent effectiveness and safety and that the two forms can be directly converted by dividing the total daily dose by the number of times the drug is taken each day. During the 21-day open-label period, 50, 75 or 100mg of the IR form is given orally every 4 or 6 hours, starting with 50mg every 6 hours. Then, the dose, the frequency of giving the drug, or both may be increased, to a maximum TDD of 500mg, or decreased in 50 mg increments, with minimum TDD of 200 mg, until the optimal stable dose for a patient is found. During the 2 double-blind periods, a TDD approximately equivalent to the stable open-label dose is given orally in IR (or ER) form or placebo.

Conditions: Low Back Pain
Being tested: tapentadol (CG5503) Immediate Release IR, tapentadol (CG5503) Extended Release (ER), tapentadol (CG5503) Immediate Release (IR)
Keywords: Low Back Pain, Dose Equivalence, Tapentadol (CG5503), Tapentadol-IR, Tapentadol-ER
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tapentadol (CG5503) Immediate Release IRDrug
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
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
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

Study groups in NCT00594516
Study group	Role	What they receive
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 Receives: Drug: tapentadol (CG5503) Immediate Release IR; Drug: 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 Receives: Drug: tapentadol (CG5503) Extended Release (ER)

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 14 days for each cross-over period

Secondary outcomes (4)

The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment
Measured: 14 days for each cross-over period
The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment
Measured: 14 days for each cross-over period
Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period
Average total daily dose (TDD) of tapentadol IR during the double blind treatment period
Measured: 14-day for each DB treatment period
Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.
Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.
Measured: 14 days for each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007May 2008

First posted15 Jan 2008 (estimated)
Study startDec 2007
Primary completionApr 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00594516
Sponsor's protocol ID: CR014242
Other IDs: R331333PAI3019
Status last verified: Mar 2015
First submitted: 3 Jan 2008
Last updated: 15 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 20119464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
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Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, 2-Period, Crossover Study to Establish the Dose Equivalence and Direct Conversion Between Immediate Release (IR) and Extended-Release (ER) CG5503 in Subjects With Moderate-to-Severe, Chronic Low Back Pain
ClinicalTrials.gov ID: NCT00594516
Acronym / sponsor ID: CR014242
Conditions: Low Back Pain
Keywords: Low Back Pain, Dose Equivalence, Tapentadol (CG5503), Tapentadol-IR, Tapentadol-ER
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
Collaborators: Grünenthal GmbH
Study start: Dec 2007
Primary completion: Apr 2008 (actual)
Study completion: May 2008 (actual)
First posted: 15 Jan 2008 (estimated)
Results: Posted 26 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
001	Experimental	Drug: tapentadol (CG5503) Immediate Release IR, Drug: tapentadol (CG5503) Immediate Release (IR)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
002	Experimental	Drug: tapentadol (CG5503) Extended Release (ER)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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tapentadol (CG5503) Immediate Release IR21 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	001
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	002
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	Drug	001

Primary outcome

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)
Time frame: 14 days for each cross-over period
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".

4 secondary outcomes

The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment
Time frame: 14 days for each cross-over period
The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment
Time frame: 14 days for each cross-over period
Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period
Time frame: 14-day for each DB treatment period
Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.
Time frame: 14 days for each treatment period

Results and safety

Results posted to the registry on 26 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tapentadol	116	87
Tapentadol IR to ER	0	0
Tapentadol ER to IR	0	0

Primary outcome: 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)

Time frame: 14 days for each cross-over period. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	Tapentadol n = 60
Value	0.1 (-0.09 to 0.28)

Tapentadol: Mean Difference (Final Values): 0.1 (95% CI -0.09 to 0.28)

Population analysed: Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tapentadol	2 of 116 (1.7%)	98 of 116 (84.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20119464Etropolski 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.

Related trials for Low Back Pain

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Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director

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

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 14 days for each cross-over period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00594516, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.