Trial Outcomes & Findings for A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain (NCT NCT00833040)
NCT ID: NCT00833040
Last Updated: 2015-01-01
Results Overview
time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
30 minutes after dosing
Results posted on
2015-01-01
Participant Flow
42 patients were enrolled and entered the Titration Phase. 36 patients determined an effective dosage of sufentanil and were randomized to the Double-Blind Phase of the study. 2 patients then terminated from the study and did not take any doses after the Titration Phase. 34 patients participated in the Double-Blind Phase of the study.
Participant milestones
| Measure |
Sequence 1
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 2
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 3
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 4
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 5
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 6
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 2
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 3
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 4
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 5
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
Sequence 6
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain
Baseline characteristics by cohort
| Measure |
Sufentanil Followed by Sufentanil and PBO
n=34 Participants
During the Titration Phase, patients titrated to the effective dosage of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken as needed for breakthrough pain.
During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active (dosage determined in Titration Phase) and three placebo doses taken in random order per. One NanoTab™ was taken as needed for breakthrough pain.
|
|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after dosingPopulation: Intent to treat population defined as all patients who took at least one dose of study drug
time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.
Outcome measures
| Measure |
Double Blind Phase of 7 Sufentanil Tablets
n=34 Participants
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
|
Double Blind Phase of 3 Pbo Tablets
n=34 Participants
Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
|
|---|---|---|
|
Time-weighted SPID30
|
59.9 units on a scale
Standard Error 6.25
|
42.6 units on a scale
Standard Error 6.86
|
Adverse Events
Titration of Sufentanil Followed by Sufentanil and PBO
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Titration of Sufentanil Followed by Sufentanil and PBO
n=34 participants at risk
During the Titration Phase, patients titrated to their personal effective strength of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken for each episode of breakthrough pain.
During the Double-Blind Phase, patients were randomized to one of six treatment sequences, each of which included seven active doses (the strength determined in Titration Phase) and three placebo doses. The ten doses were in random order. One NanoTab™ was taken for each episode of breakthrough pain.
|
|---|---|
|
Nervous system disorders
Aphasia
|
2.9%
1/34 • The length of the study varied for each patient. AEs were reported and collected during the titration period and well as the treatment period and for 12 hour after the last dose of study medication.
|
|
Nervous system disorders
Decreased Cognition
|
2.9%
1/34 • The length of the study varied for each patient. AEs were reported and collected during the titration period and well as the treatment period and for 12 hour after the last dose of study medication.
|
|
Nervous system disorders
Right Hemiparesis
|
2.9%
1/34 • The length of the study varied for each patient. AEs were reported and collected during the titration period and well as the treatment period and for 12 hour after the last dose of study medication.
|
|
Nervous system disorders
Lethargy
|
2.9%
1/34 • The length of the study varied for each patient. AEs were reported and collected during the titration period and well as the treatment period and for 12 hour after the last dose of study medication.
|
|
Nervous system disorders
Sedation
|
2.9%
1/34 • The length of the study varied for each patient. AEs were reported and collected during the titration period and well as the treatment period and for 12 hour after the last dose of study medication.
|
|
Nervous system disorders
Confusion
|
2.9%
1/34 • The length of the study varied for each patient. AEs were reported and collected during the titration period and well as the treatment period and for 12 hour after the last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication without prior written consent
- Publication restrictions are in place
Restriction type: OTHER