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

Purpose

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.

Condition	Intervention	Phase
Pain Breakthrough Cancer Pain	Drug: SSR411298 Drug: Placebo (for SSR411298)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Constipation

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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 [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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 [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
Opioid consumption expressed as the morphine-equivalent dose per day [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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) [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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 [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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 [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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 [ Time Frame: 5 weeks (from D-7 (seven days before randomization) up to D28) ] [ Designated as safety issue: No ]
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) [ Time Frame: up to 5 weeks (from 1st study drug intake up to 7 days after last study drug intake) ] [ Designated as safety issue: Yes ]
SSR411298 plasma concentration [ Time Frame: predose and 3-5 hours after study drug intake on Day D14 and Day 28 ] [ Designated as safety issue: No ]
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.

Enrollment:	5
Study Start Date:	January 2012
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SSR411298 200 mg SSR411298 200 mg, one tablet once daily for 4 weeks	Drug: SSR411298 Form: tablet Route: oral administration with food
Placebo Comparator: Placebo Placebo (for SSR411298), one tablet once daily for 4 weeks	Drug: Placebo (for SSR411298) Form: tablet Route: oral administration with food

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439919

Locations

United States, North Carolina
Investigational Site Number 840006
Flat Rock, North Carolina, United States, 28731
United States, Ohio
Investigational Site Number 840005
Canton, Ohio, United States, 44718

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01439919 History of Changes
Other Study ID Numbers:	ACT11705, 2011-002557-56, U1111-1115-3390
Study First Received:	September 7, 2011
Last Updated:	March 14, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013

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