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A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain (ACT11705)

Primary Purpose

Pain, Breakthrough Cancer Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SSR411298
Placebo (for SSR411298)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

  • 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.

Sites / Locations

  • Investigational Site Number 840006
  • Investigational Site Number 840005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SSR411298 200 mg

Placebo

Arm Description

SSR411298 200 mg, one tablet once daily for 4 weeks

Placebo (for SSR411298), one tablet once daily for 4 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Breakthrough pain frequency
Opioid consumption expressed as the morphine-equivalent dose per day
Rescue medication consumption expressed as the number of rescue medication doses per day
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.
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.
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).
Healthcare utilization
Healthcare utilization is measured as the number unscheduled hospitalizations, emergency department visits, healthcare provider office visits, and sick leave days.
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.
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.
Overview of adverse events (AE)
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.

Full Information

First Posted
September 7, 2011
Last Updated
March 14, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01439919
Brief Title
A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
Acronym
ACT11705
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
due to strategic reasons
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Breakthrough Cancer Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSR411298 200 mg
Arm Type
Experimental
Arm Description
SSR411298 200 mg, one tablet once daily for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for SSR411298), one tablet once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
SSR411298
Intervention Description
Form: tablet Route: oral administration with food
Intervention Type
Drug
Intervention Name(s)
Placebo (for SSR411298)
Intervention Description
Form: tablet Route: oral administration with food
Primary Outcome Measure Information:
Title
Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
Description
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.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Secondary Outcome Measure Information:
Title
Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores
Description
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.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Responder rates
Description
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.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Breakthrough pain frequency
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Opioid consumption expressed as the morphine-equivalent dose per day
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
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)
Title
Mood disorders as measured by the Hospital, Anxiety & Depression Scale (HADS)
Description
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.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Change in nausea as measured by Visual Analog Scale (VAS)
Description
The nausea VAS is a patient-centered instrument to measure nausea on a continuous 100-mm scale.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Constipation as measured by the Bowel Function Index (BFI)
Description
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).
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Healthcare utilization
Description
Healthcare utilization is measured as the number unscheduled hospitalizations, emergency department visits, healthcare provider office visits, and sick leave days.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
Patient satisfaction of pain relief
Description
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.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
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
Description
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.
Time Frame
5 weeks (from D-7 (seven days before randomization) up to D28)
Title
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)
Title
SSR411298 plasma concentration
Description
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.
Time Frame
predose and 3-5 hours after study drug intake on Day D14 and Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840006
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
Investigational Site Number 840005
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States

12. IPD Sharing Statement

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A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain

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