PainPhase 3NCT00505414
A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine
A Phase 3 study testing Tapentadol in the Titration Phase, Morphine in the Maintenance Phase and Tapentadol in the Maintenance Phase in people with Pain and Neoplasm, run by Grünenthal GmbH at 37 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Tapentadol in the Titration Phase, Morphine in the Maintenance Phase and Tapentadol in the Maintenance Phase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 37 sitesin 6 countries
- Study dates
- Jun 2007to May 2009
- 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
- A signed informed consent document.
- Male and non-pregnant, non-lactating female subjects.
- Female subjects must be post menopausal, surgically sterile, or practicing an effective method of birth control and continue to do so throughout the trial.
- At least 18 years of age.
- Have chronic malignant tumor-related pain
- Are opioid-naïve or have been pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.
- Have a mean pain intensity of at least 5 points on an 11-point Numeric Rating Scale (where 0 indicates no pain and 10 indicates worst possible pain).
- Have an expected course of the disease such that the pain that will permit compliance with the trial protocol over the entire trial period.
Who cannot join
- Have a life-long history of seizure disorder or epilepsy.
- Have had any of the following within one year: mild/moderate traumatic brain injury, stroke, and transient ischemic attack.
- Have had severe traumatic brain injury within 15 years (consisting of ≥ 1 of the following: brain contusion, intracranial hematoma, and either unconsciousness or post-traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness.
- Have a known history and/or presence of cerebral metastases.
- Have moderately or severely impaired hepatic function.
- Have laboratory values reflecting inadequate hepatic function.
Show all 12Show fewer
- Have thrombopenia, leucopenia or hypercalcemia
- Have severely impaired renal function.
- Having uncontrolled hypertension
- Having clinically relevant history of hypersensitivity, allergy or contraindications to morphine or any of the excipients.
- Have chronic hepatitis B or hepatitis C, or Human Immunodeficiency Virus (HIV).
- Subjects currently undergoing the following concomitant therapy: radiotherapy, pain inducing chemotherapy, anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine re-uptake inhibitors (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial. Selective serotonin re-uptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days before the screening period of the trial at an unchanged dose.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
Argentina9 sites
54009
Ciudad de Buenos Aires, C1185AAT
054003
La Plata, Buenos Aires, B1900BAJ
054012
Pergamino, Buenos Aires, B2700CPM
054022
Quilmes, Buenos Aires, B1878AAT
054010
Rosario, Santa Fe Province, S2000CVD
054013
Rosario, Santa Fe Province, S2000CVD
054005
San Miguel de Tucumán, Tucumán Province, T4000IAK
054015
Santa Fe, S3000FFU
054008
Villa Domínico, Buenos Aires, B1874ACL
Ukraine9 sites
380015
Cherkasy, 18009
380011
Donetsk, 83092
380012
Donetsk, 83092
380008
Kharkiv, 61024
380002
Kharkiv, 61070
380013
Kiev, 01601
380001
Kiev, 61070
380009
Lviv, 79031
380010
Poltava, 36011
United States7 sites
001015
Canton, Ohio, 44718
001010
Cedarhurst, New York, 11516
001002
Elkhart, Indiana, 46514
001003
Glens Falls, New York, 12801
001001
Shreveport, Louisiana, 71103
001013
St. Petersburg, Florida, 80918
001004
Winston-Salem, North Carolina, 27103
Chile7 sites
056006
Coquimbo
056011
Santiago, 7510009
056008
Santiago, 8380000
056005
Santiago
056003
Talcahuano
056004
Temuco
056012
Valparaíso, 236-3058
About this study
Official title: A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
Read the detailed description
Normally chronic tumor related pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol, a newly synthesized drug with an Prolonged Release (ER) formulation, also acts as a centrally acting pain reliever but has a dual mode of action.
The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of Tapentadol Prolonged Release (ER) compared to a tablet with no active ingredient drug (placebo) and a corresponding dose of Morphine (an opioid commonly used to treat tumor related pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, randomized-withdrawal, multicenter trial. To maintain the blind all subjects were re-randomized at the start of the maintenance period. To maintain the blind all tapentadol subjects were re-randomized at the start of the maintenance period. Subjects that received morphine in the titration period continued in the maintenance period on morphine.
The trial includes a 2 week titration phase starting with either 45 mg Morphine Sulfate Controlled Release (CR) twice daily or 100 mg tapentadol ER taken twice daily (bid). Based on effectiveness and side effects participants can up-titrate in steps of 50 mg Tapentadol ER or 15 mg Morphine Sulfate CR to a maximal dose of 250 mg Tapentadol ER bid or 90 mg Morphine Sulfate CR twice daily respectively. If subjects meet the stabilization criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase.
Assessments of pain relief, defined as a responder include the pain intensity numeric rating scale (NRS). The Patient Global Impression of Change scale (PGIC) will also be used as a secondary efficacy endpoint. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of tapentadol.
- Being tested
- Tapentadol in the Titration Phase, Morphine in the Maintenance Phase, Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase, Tapentadol in the Maintenance Phase, Morphine in the Titration Phase
- Keywords
- Chronic Tumor Related Pain, Analgesic, Tapentadol Extended Release, Morphine Sulfate Controlled Release, Pain assessment, Placebo
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol in the Titration PhaseDrug
Also called Palexia, Nucynta
Morphine in the Maintenance PhaseDrug
Also called MS Contin overencapsulated for blinding
Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. In the maintenance phase participants continued on the dose level established in titration phase.
Participants randomized to the morphine arm remained on morphine if they qualified for the maintenance phase of the study. The participants were maintained on the dose established at the end of the titration phase. The adverse events listed were documented in the maintenance phase.
Matching Placebo in the Maintenance Phase after Tapentadol in the Titration PhaseDrug
Participant randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
Tapentadol in the Maintenance PhaseDrug
The participants re-randomized to receive tapentadol prolonged release in the maintenance phase were maintained on the dose established in the titration phase.
Morphine in the Titration PhaseDrug
After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses). Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted.
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase). Receives: Drug: Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase |
| Morphine Controlled Release | Active comparator | Oral Morphine 45 mg to 90 mg twice daily. Receives: Drug: Morphine in the Maintenance Phase; Drug: Morphine in the Titration Phase |
| Tapentadol Extended Release | Experimental | Oral Tapentadol 100 mg to 250 mg twice daily. Receives: Drug: Tapentadol in the Titration Phase; Drug: Tapentadol in the Maintenance Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rates in Maintenance Period
A "responder" is a participant in the study that:
- completed 28 days of the maintenance phase
- had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.
- did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43).
A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder.
Measured: End of the 4 week Maintenance Phase (Day 43)
Secondary outcomes (1)
Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) is an instrument where the participant indicates their perceived change at the end of a treatment phase. The overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in tapentadol and morphine at Day 15 (Start of Maintenance Phase) and repeated in participants completing the Maintenance Phase in the Matching Placebo, Tapentadol and Morphine (Day 43).
Measured: Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionMay 2009
Why it stopped: Recall of rescue medication, alternative rescue medication availability issues.
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.
- Other trials for 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- P. Poulain, Dr., Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505414
- Sponsor's protocol ID
- 672519
- Other IDs
- 2007-001985-34, KF5503/16
- Status last verified
- Oct 2019
- First submitted
- 19 Jul 2007
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.
- ClinicalTrials.gov ID
- NCT00505414
- Acronym / sponsor ID
- 672519
- Keywords
- Chronic Tumor Related Pain, Analgesic, Tapentadol Extended Release, Morphine Sulfate Controlled Release, Pain assessment, Placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recall of rescue medication, alternative rescue medication availability issues.
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Posted 2 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
Detailed description
Normally chronic tumor related pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol, a newly synthesized drug with an Prolonged Release (ER) formulation, also acts as a centrally acting pain reliever but has a dual mode of action.
The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of Tapentadol Prolonged Release (ER) compared to a tablet with no active ingredient drug (placebo) and a corresponding dose of Morphine (an opioid commonly used to treat tumor related pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, randomized-withdrawal, multicenter trial. To maintain the blind all subjects were re-randomized at the start of the maintenance period. To maintain the blind all tapentadol subjects were re-randomized at the start of the maintenance period. Subjects that received morphine in the titration period continued in the maintenance period on morphine.
The trial includes a 2 week titration phase starting with either 45 mg Morphine Sulfate Controlled Release (CR) twice daily or 100 mg tapentadol ER taken twice daily (bid). Based on effectiveness and side effects participants can up-titrate in steps of 50 mg Tapentadol ER or 15 mg Morphine Sulfate CR to a maximal dose of 250 mg Tapentadol ER bid or 90 mg Morphine Sulfate CR twice daily respectively. If subjects meet the stabilization criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase.
Assessments of pain relief, defined as a responder include the pain intensity numeric rating scale (NRS). The Patient Global Impression of Change scale (PGIC) will also be used as a secondary efficacy endpoint. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of tapentadol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching Placebo in the Maintenance Phase after Tapentadol in the Titration PhaseOral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase). |
| Morphine Controlled Release | Active comparator | Drug: Morphine in the Maintenance Phase, Drug: Morphine in the Titration PhaseOral Morphine 45 mg to 90 mg twice daily. |
| Tapentadol Extended Release | Experimental | Drug: Tapentadol in the Titration Phase, Drug: Tapentadol in the Maintenance PhaseOral Tapentadol 100 mg to 250 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A signed informed consent document.
- Male and non-pregnant, non-lactating female subjects.
- Female subjects must be post menopausal, surgically sterile, or practicing an effective method of birth control and continue to do so throughout the trial.
- At least 18 years of age.
- Have chronic malignant tumor-related pain
Key exclusion criteria (12 listed)
- Have a life-long history of seizure disorder or epilepsy.
- Have had any of the following within one year: mild/moderate traumatic brain injury, stroke, and transient ischemic attack.
- Have had severe traumatic brain injury within 15 years (consisting of ≥ 1 of the following: brain contusion, intracranial hematoma, and either unconsciousness or post-traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness.
- Have a known history and/or presence of cerebral metastases.
- Have moderately or severely impaired hepatic function.
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 in the Titration PhaseAlso: Palexia, Nucynta | Drug | Tapentadol Extended Release |
| Morphine in the Maintenance PhaseAlso: MS Contin overencapsulated for blindingParticipant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. In the maintenance phase participants continued on the dose level established in titration phase. Participants randomized to the morphine arm remained on morphine if they qualified for the maintenance phase of the study. The participants were maintained on the dose established at the end of the titration phase. The adverse events listed were documented in the maintenance phase. | Drug | Morphine Controlled Release |
| Matching Placebo in the Maintenance Phase after Tapentadol in the Titration PhaseParticipant randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily. | Drug | Matching Placebo |
| Tapentadol in the Maintenance PhaseThe participants re-randomized to receive tapentadol prolonged release in the maintenance phase were maintained on the dose established in the titration phase. | Drug | Tapentadol Extended Release |
| Morphine in the Titration PhaseAfter signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses). Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. | Drug | Morphine Controlled Release |
Primary outcome
Responder Rates in Maintenance Period
Time frame: End of the 4 week Maintenance Phase (Day 43)
A "responder" is a participant in the study that: 1. completed 28 days of the maintenance phase 2. had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43. 3. did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43). A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder.
1 secondary outcome
Patient Global Impression of Change (PGIC)
Time frame: Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
P. Poulain, Dr. principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tapentadol in the Titration Phase, Morphine in the Maintenance Phase and Tapentadol in the Maintenance Phase in people with Pain and Neoplasm, run by Grünenthal GmbH at 37 sites in 6 countries.
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 8 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: stopped early, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Argentina, Ukraine, United States, Chile, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 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?
Responder Rates in Maintenance Period (time frame: End of the 4 week Maintenance Phase (Day 43)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.