PainPhase 3TRAPEZENCT00375648
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
A Phase 3 study testing Zoledronic acid in people with Pain, run by Novartis Pharmaceuticals at 1 site in France.
Trial summary
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the prostate
- Bone-scan documented metastases
- Age > 18 years
- Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
- Life expectancy > 3 months
- Written informed consent
Who cannot join
- New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
- Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
- Bisphosphonate therapy within 8 weeks before study entry
- Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine clearance < 30 ml/min)
- Corrected serum calcium > 3 mmol/L or < 2 mmol/L
- Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug
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- Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain
- Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
- Conditions
- Pain
- Being tested
- Zoledronic acid
- Keywords
- Prostate, Cancer, Bone metastases, Zoledronic acid, Bone metastases-related pain, Prostate cancer
- Medical subject headings
- Pain, Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| zoledronate | Experimental | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)
Measured: at 12 weeks or at 16 weeks (end of treatment)
Secondary outcomes (8)
To measure the intensity of the pain relief of the patients with the PAR at each visit
Measured: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.
Measured: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)
Measured: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5
Measured: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the duration of responses
Measured: at 12 weeks or at 16 weeks (end of treatment)
To evaluate the number of skeletal related events by patient
Measured: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5
Measured: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal
Measured: at 12 weeks or at 16 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJun 2005
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375648
- Sponsor's protocol ID
- CZOL446EFR08
- Acronym
- TRAPEZE
- Status last verified
- May 2017
- First submitted
- 11 Sep 2006
- Last updated
- 2 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00375648
- Acronym / sponsor ID
- TRAPEZE / CZOL446EFR08
- Conditions
- Pain
- Keywords
- Prostate, Cancer, Bone metastases, Zoledronic acid, Bone metastases-related pain, Prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jul 2007 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zoledronate | Experimental | Drug: Zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven adenocarcinoma of the prostate
- Bone-scan documented metastases
- Age > 18 years
- Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
- Life expectancy > 3 months
Key exclusion criteria (9 listed)
- New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
- Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
- Bisphosphonate therapy within 8 weeks before study entry
- Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine clearance < 30 ml/min)
- Corrected serum calcium > 3 mmol/L or < 2 mmol/L
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 |
|---|---|---|
| Zoledronic acid | Drug | zoledronate |
Primary outcome
to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)
Time frame: at 12 weeks or at 16 weeks (end of treatment)
8 secondary outcomes
To measure the intensity of the pain relief of the patients with the PAR at each visit
Time frame: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.
Time frame: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)
Time frame: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5
Time frame: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the duration of responses
Time frame: at 12 weeks or at 16 weeks (end of treatment)
To evaluate the number of skeletal related events by patient
Time frame: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5
Time frame: every 3 or 4 weeks during 12 to 16 weeks
To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal
Time frame: at 12 weeks or at 16 weeks (end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid in people with Pain, run by Novartis Pharmaceuticals at 1 site in France.
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 6 inclusion and 9 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief) (time frame: at 12 weeks or at 16 weeks (end of treatment)). 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 2 Jun 2017.