PainPhase 2ACT11705NCT01439919
A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
A Phase 2 study testing SSR411298 in people with Pain and Breakthrough Cancer Pain, run by Sanofi at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Breakthrough Cancer Pain
- What is being tested?
- SSR411298
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Feb 2012
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with moderate or severe, persistent cancer pain who is receiving the World Health Organization (WHO) Step 2 or 3 cancer pain treatment:
- Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment;
- Pain generator (source of pain) must be classified as either primarily nociceptive or primarily neuropathic;
- Pain severity must be moderate or severe with an average NRS score ≥4 during the screening week.
Who cannot join
- Instability of pain during the screening week;
- Use of prohibited adjuvant pain treatment in the week prior to study entry or plan to use these medications during the study;
- Current use of medication containing tetrahydrocannabinol (THC);
- Chemotherapy within 4 weeks before study entry or chemotherapy planned during the study (a stable regiment of hormonal therapy is permitted);
- Radiotherapy within 4 weeks before study entry or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted);
- Cancer related surgery within 4 weeks before study entry or cancer-related surgery planned during the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Investigational Site Number 840005
Canton, Ohio, 44718
Investigational Site Number 840006
Flat Rock, North Carolina, 28731
About this study
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS).
Secondary Objectives are:
- To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life;
- To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain;
- To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment;
- To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain;
- To assess endocannabinoid plasma concentrations.
Read the detailed description
The total study duration for a participant is 6 weeks (1-week screening, 4-week treatment and 1-week post-treatment follow-up).
Participants continue to receive WHO Step 2 or 3 cancer pain treatment as background therapy.
- Conditions
- Pain, Breakthrough Cancer Pain
- Being tested
- SSR411298, Placebo (for SSR411298)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSR411298Drug
Form: tablet
Route: oral administration with food
Placebo (for SSR411298)Drug
Form: tablet
Route: oral administration with food
| Study group | Role | What they receive |
|---|---|---|
| SSR411298 200 mg | Experimental | SSR411298 200 mg, one tablet once daily for 4 weeks Receives: Drug: SSR411298 |
| Placebo | Placebo comparator | Placebo (for SSR411298), one tablet once daily for 4 weeks Receives: Drug: Placebo (for SSR411298) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
The NRS is an 11-category descriptive anchor scale that is one of the most frequently employed and accepted scales for pain evaluation. Score ranges from 0 [no pain] to 10 [worst possible pain].
Average NRS score is defined as the average of pain intensity scores measured daily by NRS during a week.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Secondary outcomes (13)
Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores
The BPI-SF is a 9-point questionnaire that measures the intensity of pain, interference of pain, pain relief, pain quality, and patient perception of the cause of pain.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Responder rates
Responders are defined as:
- reduction from baseline ≥30% of pain intensity as measured by NRS;
- reduction from baseline ≥50% of pain intensity as measured by NRS;
- composite of decrease in pain intensity or decrease in background therapy utilization.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Breakthrough pain frequency
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Opioid consumption expressed as the morphine-equivalent dose per day
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Rescue medication consumption expressed as the number of rescue medication doses per day
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Mood disorders as measured by the Hospital, Anxiety & Depression Scale (HADS)
The HADS is a self-reported scale that contains 14 items rated on 4-point Likert scales. Two subscales assess depression (7 items) and anxiety (7 items). Each 7-item subscale yields a score of 0 to 21 that is interpreted with the following cut points: 0-7, normal; 8-10, mild mood disturbance; 11-14, moderate mood disturbance; and 12-21, severe mood disturbance.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Change in nausea as measured by Visual Analog Scale (VAS)
The nausea VAS is a patient-centered instrument to measure nausea on a continuous 100-mm scale.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Constipation as measured by the Bowel Function Index (BFI)
The BFI is a 3-item questionnaire to measure constipation from the patient's perspective. The time frame for the questions is "during the last 7 days". The answer for each of the 3 items is rated on a scale from 0 (easy or no difficulty) to 100 (severe difficulty).
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Healthcare utilization
Healthcare utilization is measured as the number unscheduled hospitalizations, emergency department visits, healthcare provider office visits, and sick leave days.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Patient satisfaction of pain relief
Patient satisfaction of pain relief is a 5-point Likert scale that measures patient satisfaction with treatment. The five categorical responses are: extremely unsatisfied, unsatisfied, neutral, satisfied, extremely satisfied.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) version 3
The EORTC QLQ-C30 questionnaire contains a total of 30 items, of which 28 items are rated on 4-point Likert-type scale and 2 items are rated on 7-point Likert scale. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items.
A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: 5 weeks (from D-7 (seven days before randomization) up to D28)
Overview of adverse events (AE)
Measured: up to 5 weeks (from 1st study drug intake up to 7 days after last study drug intake)
SSR411298 plasma concentration
Plasma concentrations of SSR411298 will be determined by a validated liquid chromatography method coupled with tandem mass spectrometry (LC-MS/MS) with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: predose and 3-5 hours after study drug intake on Day D14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: due to strategic reasons
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 SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439919
- Sponsor's protocol ID
- ACT11705
- Other IDs
- 2011-002557-56, U1111-1115-3390
- Acronym
- ACT11705
- Status last verified
- Mar 2013
- First submitted
- 7 Sep 2011
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
- ClinicalTrials.gov ID
- NCT01439919
- Acronym / sponsor ID
- ACT11705 / ACT11705
- Conditions
- Pain, Breakthrough Cancer Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to strategic reasons
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Sep 2011 (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.
The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS).
Secondary Objectives are:
- To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life;
- To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain;
- To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment;
- To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain;
- To assess endocannabinoid plasma concentrations.
Detailed description
The total study duration for a participant is 6 weeks (1-week screening, 4-week treatment and 1-week post-treatment follow-up).
Participants continue to receive WHO Step 2 or 3 cancer pain treatment as background therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSR411298 200 mg | Experimental | Drug: SSR411298SSR411298 200 mg, one tablet once daily for 4 weeks |
| Placebo | Placebo comparator | Drug: Placebo (for SSR411298)Placebo (for SSR411298), one tablet once daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with moderate or severe, persistent cancer pain who is receiving the World Health Organization (WHO) Step 2 or 3 cancer pain treatment:
- Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment;
- Pain generator (source of pain) must be classified as either primarily nociceptive or primarily neuropathic;
- Pain severity must be moderate or severe with an average NRS score ≥4 during the screening week.
Key exclusion criteria (7 listed)
- Instability of pain during the screening week;
- Use of prohibited adjuvant pain treatment in the week prior to study entry or plan to use these medications during the study;
- Current use of medication containing tetrahydrocannabinol (THC);
- Chemotherapy within 4 weeks before study entry or chemotherapy planned during the study (a stable regiment of hormonal therapy is permitted);
- Radiotherapy within 4 weeks before study entry or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted);
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 |
|---|---|---|
| SSR411298Form: tablet Route: oral administration with food | Drug | SSR411298 200 mg |
| Placebo (for SSR411298)Form: tablet Route: oral administration with food | Drug | Placebo |
Primary outcome
Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
The NRS is an 11-category descriptive anchor scale that is one of the most frequently employed and accepted scales for pain evaluation. Score ranges from 0 [no pain] to 10 [worst possible pain]. Average NRS score is defined as the average of pain intensity scores measured daily by NRS during a week.
13 secondary outcomes
Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Responder rates
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Breakthrough pain frequency
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Opioid consumption expressed as the morphine-equivalent dose per day
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Rescue medication consumption expressed as the number of rescue medication doses per day
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Mood disorders as measured by the Hospital, Anxiety & Depression Scale (HADS)
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Change in nausea as measured by Visual Analog Scale (VAS)
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Constipation as measured by the Bowel Function Index (BFI)
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Healthcare utilization
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Patient satisfaction of pain relief
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) version 3
Time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Overview of adverse events (AE)
Time frame: up to 5 weeks (from 1st study drug intake up to 7 days after last study drug intake)
SSR411298 plasma concentration
Time frame: predose and 3-5 hours after study drug intake on Day D14 and Day 28
Results and safety
The study was stopped early (reason given: due to strategic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSR411298 in people with Pain and Breakthrough Cancer Pain, run by Sanofi at 2 sites in United States.
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 4 inclusion and 7 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 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: due to strategic reasons). Results are not available in the source record.
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?
Change from baseline in average Numeric Rating Scale (NRS) pain intensity score (time frame: 5 weeks (from D-7 (seven days before randomization) up to D28)). 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 21 Mar 2013.