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Trial Outcomes & Findings for RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. (NCT NCT01809106)

NCT ID: NCT01809106

Last Updated: 2015-12-24

Results Overview

Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/\< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity "stable" or "worsened" at day 28 compared with baseline values.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

518 participants

Primary outcome timeframe

28 days

Results posted on

2015-12-24

Participant Flow

Date of First Enrollment: May 2014 Date of last enrollment: July 2014

Participant milestones

Participant milestones
Measure
Morphine
Morphine: 60 mg /24 ore
Oxycodone
Oxycodone: 40 mg /24 ore
Buprenorphine
Buprenorphine: 35 microg/h
Fentanyl
Fentanyl: 25 microg/h
Overall Study
STARTED
130
130
130
128
Overall Study
COMPLETED
122
125
127
124
Overall Study
NOT COMPLETED
8
5
3
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Morphine
n=122 Participants
Morphine: 60 mg /24 ore
Oxycodone
n=125 Participants
Oxycodone: 40 mg /24 ore
Buprenorphine
n=127 Participants
Buprenorphine: 35 microg/h
Fentanyl
n=124 Participants
Fentanyl: 25 microg/h
Total
n=498 Participants
Total of all reporting groups
Age, Continuous
67.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
66.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
65.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
68 years
STANDARD_DEVIATION 10.6 • n=4 Participants
66.9 years
STANDARD_DEVIATION 11.8 • n=21 Participants
Sex: Female, Male
Female
55 Participants
n=5 Participants
53 Participants
n=7 Participants
59 Participants
n=5 Participants
54 Participants
n=4 Participants
221 Participants
n=21 Participants
Sex: Female, Male
Male
67 Participants
n=5 Participants
72 Participants
n=7 Participants
68 Participants
n=5 Participants
70 Participants
n=4 Participants
277 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Intention-to-treat

Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/\< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity "stable" or "worsened" at day 28 compared with baseline values.

Outcome measures

Outcome measures
Measure
Morphine
n=122 Participants
Morphine: 60 mg /24 ore
Oxycodone
n=125 Participants
Oxycodone: 40 mg /24 ore
Buprenorphine
n=127 Participants
Buprenorphine: 35 microg/h
Fentanyl
n=124 Participants
Fentanyl: 25 microg/h
Proportion of Non-Responder (NR) Participants
14 participants
18 participants
14 participants
11 participants

SECONDARY outcome

Timeframe: 28 days

Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/\> 30% from visit 6 and visit 1 (NRS 0 to 10).

Outcome measures

Outcome measures
Measure
Morphine
n=122 Participants
Morphine: 60 mg /24 ore
Oxycodone
n=125 Participants
Oxycodone: 40 mg /24 ore
Buprenorphine
n=127 Participants
Buprenorphine: 35 microg/h
Fentanyl
n=124 Participants
Fentanyl: 25 microg/h
Proportion of Full-responder
89 participants
90 participants
95 participants
88 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

The proportion of subjects with an increase of opioid daily dose \> 5% compared with the basal dosage (OEI%).

Outcome measures

Outcome measures
Measure
Morphine
n=122 Participants
Morphine: 60 mg /24 ore
Oxycodone
n=125 Participants
Oxycodone: 40 mg /24 ore
Buprenorphine
n=127 Participants
Buprenorphine: 35 microg/h
Fentanyl
n=124 Participants
Fentanyl: 25 microg/h
The Opioid Escalation Index
13 participants
24 participants
18 participants
45 participants

Adverse Events

Morphine

Serious events: 5 serious events
Other events: 103 other events
Deaths: 0 deaths

Oxycodone

Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths

Buprenorphine

Serious events: 1 serious events
Other events: 108 other events
Deaths: 0 deaths

Fentanyl

Serious events: 5 serious events
Other events: 95 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Morphine
n=122 participants at risk
Morphine: 60 mg /24 ore
Oxycodone
n=125 participants at risk
Oxycodone: 40 mg /24 ore
Buprenorphine
n=127 participants at risk
Buprenorphine: 35 microg/h
Fentanyl
n=124 participants at risk
Fentanyl: 25 microg/h
Gastrointestinal disorders
bowel occlusion
0.82%
1/122 • Number of events 1
0.00%
0/125
0.00%
0/127
0.81%
1/124 • Number of events 1
General disorders
exitus
0.00%
0/122
0.00%
0/125
0.00%
0/127
0.81%
1/124 • Number of events 1
Respiratory, thoracic and mediastinal disorders
dyspnea
0.82%
1/122 • Number of events 1
0.00%
0/125
0.00%
0/127
0.81%
1/124 • Number of events 1
Nervous system disorders
hyperalgesia
0.82%
1/122 • Number of events 1
0.00%
0/125
0.00%
0/127
0.00%
0/124
Gastrointestinal disorders
asthenia
0.00%
0/122
0.00%
0/125
0.00%
0/127
0.81%
1/124 • Number of events 1
General disorders
decline general condition
0.00%
0/122
0.80%
1/125 • Number of events 1
0.00%
0/127
0.81%
1/124 • Number of events 1
Gastrointestinal disorders
oral cavity bleeding
0.00%
0/122
0.00%
0/125
0.79%
1/127 • Number of events 2
0.00%
0/124
General disorders
hyperpyrexia
1.6%
2/122 • Number of events 2
0.00%
0/125
0.00%
0/127
0.00%
0/124
Respiratory, thoracic and mediastinal disorders
atelectasis
0.82%
1/122 • Number of events 1
0.00%
0/125
0.00%
0/127
0.00%
0/124
Hepatobiliary disorders
hepatic disorder
0.00%
0/122
0.00%
0/125
0.00%
0/127
0.81%
1/124 • Number of events 1

Other adverse events

Other adverse events
Measure
Morphine
n=122 participants at risk
Morphine: 60 mg /24 ore
Oxycodone
n=125 participants at risk
Oxycodone: 40 mg /24 ore
Buprenorphine
n=127 participants at risk
Buprenorphine: 35 microg/h
Fentanyl
n=124 participants at risk
Fentanyl: 25 microg/h
General disorders
drowsiness
64.8%
79/122 • Number of events 79
59.2%
74/125 • Number of events 74
63.8%
81/127 • Number of events 81
56.5%
70/124 • Number of events 70
General disorders
Confusion
48.4%
59/122 • Number of events 59
44.0%
55/125 • Number of events 55
48.0%
61/127 • Number of events 61
37.1%
46/124 • Number of events 46

Additional Information

Dr. Oscar Corli

Mario Negri Institution

Phone: +390239014564

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place