Phase 3 N=504 Randomized Treatment

A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00261495 ↗

Enrolled (actual)

504

Serious AEs

9.1%

Results posted

Dec 2012

Primary outcome: Primary: Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population) — -2.8; -3.2 Units on a scale — p=0.011

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: OROS hydromorphone HCl (Drug); Oxycodone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Pharmaceutica N.V., Belgium
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)	-2.8; -3.2	0.011 sig
PRIMARY Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)	-2.1; -2.1	<0.001 sig
PRIMARY Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)	18.9; 48.3	—
PRIMARY Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)	18.4; 43.8	—
PRIMARY Equi-analgesic Dose at Steady-state (PP Population)	18.95; 47.82	—
PRIMARY Equi-analgesic Dose at Steady State (ITT Population)	19.50; 48.41	—
SECONDARY Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)	-1.9; -1.9	0.706
SECONDARY Change From Baseline in Sleep Quality at Week 24	-8.8; -6.2	0.065
SECONDARY Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24	-2.2; -2.0	0.348
SECONDARY Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24	-2.0; -2.0	0.616
SECONDARY Number of Subjects With Dose Escalation	27; 34; 176; 148	0.249
SECONDARY Change From Baseline in BPI Severity Score "Pain Right Now" (BPI Item 6) at Week 4	-2.2; -2.6	0.050
SECONDARY Change From Baseline in BPI Pain Severity Score "Pain at Its Least" (BPI Item 4) at Week 4	-1.3; -1.8	0.105
SECONDARY Change From Baseline in BPI Pain Severity "Pain at Its Worst" (BPI Item 3) at Week 4	-1.8; -2.1	0.058
SECONDARY Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 4	-1.9; -2.1	0.210
SECONDARY Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4	13.8; 15.2	0.941
SECONDARY Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4	-1.7; -2.0	0.073
SECONDARY Change From Baseline in BPI Pain Severity "Pain at Its Least" (BPI Item 4) at Week 24	-1.3; -1.4	0.431
SECONDARY Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 24	-1.8; -1.7	0.835
SECONDARY Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24	8.6; 11.5	0.837
SECONDARY Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24	-1.6; -1.7	0.832
SECONDARY Change From Baseline in BPI Interference Score "Interfered With General Activity" (BPI Item 9a) at Week 4	-1.6; -1.9	0.143
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 4	-1.7; -1.9	0.345
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 4	-1.2; -1.5	0.552
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 4	-1.4; -2.0	0.042 sig
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 4	-1.1; -1.4	0.171
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 4	-2.1; -2.3	0.475
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 4	-1.6; -1.9	0.359
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With General Activity" (BPI Item 9a) at Week 24	-1.6; -1.6	0.611
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 24	-1.4; -1.3	0.526
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 24	-1.1; -1.2	0.769
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 24	-1.3; -1.4	0.843
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 24	-0.7; -0.9	0.977
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 24	-1.4; -1.5	0.977
SECONDARY Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 24	-1.2; -1.3	0.902
SECONDARY Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)	-2.4; -2.4; 17.7; 23.6; -2.9; -2.8	—
SECONDARY Change From Baseline in Sleep Quality (MOS Index I) at Week 4	-10.6; -8.7	0.169
SECONDARY Change From Baseline in Sleep Quality (MOS Index II) at Week 4	-10.5; -9.0	0.245
SECONDARY Change From Baseline in Sleep Quality (MOS Index II) at Week 24	-8.9; -6.5	0.071
SECONDARY Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24	-13.1; -11.7	0.297
SECONDARY Change From Baseline in Sleep Quality, Snoring at Week 24	-1.0; -4.1	0.205
SECONDARY Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24	-5.3; -0.1	0.107
SECONDARY Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24	9.1; 7.3	0.475
SECONDARY Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24	-1.6; 3.0	0.020 sig
SECONDARY Change From Baseline in Sleep Quality, Sleep Quantity at Week 24	0.4; 0.5	0.880
SECONDARY Number of Subjects Indicating That They Had Optimal Sleep at Week 24	83; 71; 166; 171	0.320
SECONDARY Change From Baseline in Sleep Quality at Week 52	-17.6; -20.1; -2.5; -4.7; -8.4; -7.8	—
SECONDARY Number of Subjects Indicating Optimal Sleep at Week 52	27; 19; 28; 30	—
SECONDARY Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24	-2.2; -2.1; -1.6; -1.4; -2.0; -1.8	—
SECONDARY Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24	0.7; 0.4; 0.5; 0.4; 0.4; 0.4	—
SECONDARY Number of Subjects With Dose Escalation at Week 4 (ITT Population)	175; 166; 79; 84	0.575
SECONDARY Number of Subjects With Dose Escalation at Week 24 (ITT Population)	146; 145; 57; 37	0.807
SECONDARY Change From Baseline in Quality of Life (QoL) "Bodily Pain" at Week 4	13.7; 16.7	0.118
SECONDARY Change From Baseline in QoL "General Health Perceptions" at Week 4	3.9; 5.0	0.956
SECONDARY Change From Baseline in QoL "Health Transition" at Week 4	-0.4; -0.5	0.299
SECONDARY Change From Baseline in QoL "Mental Health" at Week 4	6.2; 6.6	0.471
SECONDARY Change From Baseline in QoL "Physical Functioning" at Week 4	8.7; 5.4	0.025 sig
SECONDARY Change From Baseline in QoL "Role Emotional" at Week 4	9.9; 4.7	0.556
SECONDARY Change From Baseline in QoL "Role Physical" at Week 4	13.2; 16.9	0.551
SECONDARY Change From Baseline in QoL "Social Functioning" at Week 4	10.5; 12.9	0.207
SECONDARY Change From Baseline in QoL "Vitality" at Week 4	6.4; 9.2	0.123
SECONDARY Change From Baseline in QoL "Bodily Pain" at Week 24	10.6; 11.9	0.602
SECONDARY Change From Baseline in QoL "General Health Perceptions" at Week 24	2.1; 2.2	0.647
SECONDARY Change From Baseline in QoL "Health Transition" at Week 24	-0.2; -0.1	0.627
SECONDARY Change From Baseline in QoL "Mental Health" at Week 24	2.6; 2.6	0.414
SECONDARY Change From Baseline in QoL "Physical Functioning" at Week 24	7.7; 4.4	0.010 sig
SECONDARY Change From Baseline in QoL "Role Emotional" at Week 24	0.40; -1.5	0.955
SECONDARY Change From Baseline in QoL "Role Physical" at Week 24	8.8; 9.9	0.669
SECONDARY Change From Baseline in QoL "Social Functioning" at Week 24	6.6; 5.0	0.595
SECONDARY Change From Baseline in QoL "Vitality" at Week 24	4.3; 5.6	0.543
SECONDARY Change From Baseline in QoL at Week 52	23.1; 19.6; 9.6; 5.5; -0.3; -0.1	—
SECONDARY Clinical Global Assessment of Efficacy	49; 27; 92; 92; 51; 50	—
SECONDARY Change in Dose of Study Treatment	79; 84; 102; 0; 0; 108	—
SECONDARY Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)	50; 41; 92; 0; 0; 94	—
SECONDARY Number of Drop-outs	57; 56; 4; 1; 12; 16	—
SECONDARY Number of Days With add-on Pain Medication	68.2; 66.1	—
SECONDARY Amount of add-on Pain Medication	80004.8; 76191.9	—
SECONDARY Mode and Convenience of Drug Intake.	57; 36; 97; 94; 30; 30	—
SECONDARY Resource Utilization of Pain Management	2.1; 1.9	—

Summary

The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).

Eligibility Criteria

Inclusion Criteria

Adult patients with chronic noncancer pain severe enough to require continuous opioid therapy (a score of at least 5 in "pain right now" on a 11 point numeric rating scale) who have never received an opioid or are currently treated with a weak opioid, and who experience insufficient pain control.

Exclusion Criteria

Patients who have been treated with strong opioids (including hydromorphone and oxycodone) within the last 4 weeks prior to study inclusion or who will probably undergo any treatment (e.g. neurological techniques, surgery) within the next 6 months, which may abruptly alter degree or nature of pain experienced
patients with a history of disease(s), current illness, or therapy which would preclude them from participation in the study
and patients who are pregnant or nursing.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00261495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.