Trial Outcomes & Findings for Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain (NCT NCT01207596)

Results Overview

The primary efficacy measure was the change from baseline to end of study on question #5 ("average pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain on the average," where 0 = no pain and 10 = pain as bad as you can imagine.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Baseline visit to Week 12 or last visit

Results posted on

2012-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Hydromorphone Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Overall Study STARTED	30
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydromorphone Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Overall Study Physician Decision	4
Overall Study Lack of Efficacy	1
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydromorphone n=30 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=93 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants
Age Continuous	58 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline visit to Week 12 or last visit

Population: LOCF

The primary efficacy measure was the change from baseline to end of study on question #5 ("average pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain on the average," where 0 = no pain and 10 = pain as bad as you can imagine.

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale	-1.2 units on a scale Standard Error 0.55

SECONDARY outcome

Timeframe: Baseline visit to Week 12 or last visit

Population: LOCF

Change from baseline to end of study on question #3 ("worst pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours," where 0 = no pain and 10 = pain as bad as you can imagine.

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours	-1.8 units on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: Baseline visit to Week 12 or last visit

Population: LOCF

Change from baseline to end of study on question #4 ("least pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours," where 0 = no pain and 10 = pain as bad as you can imagine.

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours	-0.9 units on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline visit to Week 12 or last visit

Population: LOCF

Change from baseline to end of study on question #4 ("current pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that tells how much pain you have right now," where 0 = no pain and 10 = pain as bad as you can imagine.

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now	-1.3 units on a scale Standard Error 0.59

SECONDARY outcome

Timeframe: Baseline visit to Week 12 or last visit

Population: LOCF

Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes)

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Sleep Quality Assessment (SQA)	-1.7 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Baseline visit to 12 weeks visit

Population: LOCF

The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Pain Quality Assessment Scale (PQAS)	-24.8 units on a scale Standard Error 7.9

SECONDARY outcome

Timeframe: Baseline visit to Week 12 or last visit

Population: LOCF

Patients were asked to rate their global assessment of treatment satisfaction, ranging from "very dissatisfied" to "very satisfied". Adverse events were monitored throughout the study

Outcome measures

Outcome measures
Measure	Hydromorphone n=26 Participants Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Global Assessment of Treatment Satisfaction Very satisfied	38.5 percentage of patients
Global Assessment of Treatment Satisfaction Satisfied	42.3 percentage of patients
Global Assessment of Treatment Satisfaction Dissatisfied	15.4 percentage of patients
Global Assessment of Treatment Satisfaction Very dissatisfied	3.8 percentage of patients

Adverse Events

Hydromorphone

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hydromorphone n=30 participants at risk Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
Nervous system disorders Headache	10.0% 3/30 • Number of events 3
Nervous system disorders Dizziness	10.0% 3/30 • Number of events 4
Gastrointestinal disorders Flu	10.0% 3/30 • Number of events 3
Psychiatric disorders Increased pain	6.7% 2/30 • Number of events 2

Additional Information

Srinivas Nalamachu

International Clinical Research Institute

Phone: 913-317-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place