An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

• Sponsor: Janssen Korea, Ltd., Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01006356
• Collaborator: (none)
• Enrollment: 141
• Arm: 1
• Duration (Months): 10

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Pain	Drug: Hydromorphone HCl OROS	Phase 4

Detailed Description

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. The total duration of study will be 3 weeks. The study consists of 2 periods and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3 and 4). During screening period at Visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. During treatment period, from second visit to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2 weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram [mg] twice daily is equal to hydromorphone HCl 8 mg once daily). The Investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydromorphone hydrochloride (HCl) oral osmotic system (OROS) Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.	Drug: Hydromorphone HCl OROS; Hydromorphone HCl OROS 8 mg once daily for 2 weeks.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain [Day 15]

   Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).

Secondary Outcome Measures

1. Frequency of Experiencing Breakthrough Pain [Day 1 and Day 15]

   Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.

2. Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15 [Baseline and Day 15]

   K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.

3. Pain Intensity Score [Day 3 and Day 13]

   Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.

4. Global Assessment of Overall Efficacy of Study Drug by Investigator [Day 15]

   Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.

5. Global Assessment of Overall Efficacy of Study Drug by Participant [Day 15]

   Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.

6. Participant's Preferences Along With Reasons [Day 15]

   The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.

7. Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score [Day 15]

   Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.

8. European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score [Day 1 and Day 15]

   EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cancer participants administering only strong oral opioid analgesic for cancer pain control

• Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)

• Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators

• Abstinent or surgically sterile female participants

Exclusion Criteria:

• Participants with cancer pain who are potentially unresponsive to narcotic analgesics

• Participants with presence or history of drug or alcohol abuse within the past 6 months

• Participants with hypersensitivity to hydromorphone HCl

• Participants with history of colectomy (surgery to remove part or all of the colon)

• Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Janssen Korea, Ltd., Korea

Investigators

• Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Korea, Ltd., Korea
• ClinicalTrials.gov Identifier: NCT01006356
• Other Study ID Numbers: CR015694; 42801PAI4006
• First Posted: Nov 1, 2009
• Last Update Posted: Aug 8, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Janssen Korea, Ltd., Korea: Hydromorphone hydrochloride Oral Osmotic System; Jurnista
• Additional relevant MeSH terms: Breakthrough Pain; Hydromorphone

Study Results

Participant Flow

Arm/Group Title	Hydromorphone Hydrochloride Oral Osmotic System
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Period Title: Overall Study
STARTED	141
COMPLETED	99
NOT COMPLETED	42

Baseline Characteristics

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Overall Participants	106
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.94 (11.27)
Sex: Female, Male (Count of Participants)
Female	37 34.9%
Male	69 65.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
Description	Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	106
Number [Percentage of Participants]	50.9 48%

2. Secondary Outcome

Title	Frequency of Experiencing Breakthrough Pain
Description	Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	106
Day 1: Incidental Pain	1.1 (1.4)
Day 15: Incidental Pain	0.8 (1.1)
Day 1: Idiopathic Pain	1.8 (1.6)
Day 15: Idiopathic Pain	1.2 (1.3)
Day 1: End-of-dose failure	1.0 (1.6)
Day 15: End-of-dose failure	0.6 (1.0)

3. Secondary Outcome

Title	Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
Description	K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.
Time Frame	Baseline and Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	106
Baseline	3.66 (1.29)
Change at Day 15	0.359 (1.191)

4. Secondary Outcome

Title	Pain Intensity Score
Description	Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.
Time Frame	Day 3 and Day 13

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	106
Day 3 (8 AM) (n=106)	3.7 (1.8)
Day 3 (8 PM) (n=106)	3.6 (1.8)
Day 13 (8 AM) (n=103)	3.3 (1.8)
Day 13 (8 PM) (n=103)	3.3 (1.8)

5. Secondary Outcome

Title	Global Assessment of Overall Efficacy of Study Drug by Investigator
Description	Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	104
Ineffective response	4 3.8%
Average response	37 34.9%
Effective response	48 45.3%
Very effective response	12 11.3%
Highly effective response	3 2.8%

6. Secondary Outcome

Title	Global Assessment of Overall Efficacy of Study Drug by Participant
Description	Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here "N" signifies participants evaluated for this outcome measure.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	104
Ineffective	9 8.5%
Average	31 29.2%
Effective	49 46.2%
Very effective	12 11.3%
Highly effective	3 2.8%

7. Secondary Outcome

Title	Participant's Preferences Along With Reasons
Description	The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	100
Hydromorphone OROS:Consistent effect(n=91)	33 31.1%
Oral Opioid: Consistent effect(n=9)	1 0.9%
Hydromorphone OROS: Sleep undisturbed(n=91)	3 2.8%
Hydromorphone OROS:reduced intake frequency(n=91)	74 69.8%
Hydromorphone OROS:reduced intake(n=91)	29 27.4%
Hydromorphone OROS:Other(n=91)	2 1.9%
Oral Opioid: Other(n=9)	8 7.5%
Oral Opioid: No response(n=9)	1 0.9%

8. Secondary Outcome

Title	Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Description	Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.
Time Frame	Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	104
greatly improved	3 2.8%
somewhat improved	23 21.7%
slightly improved	45 42.5%
no change	30 28.3%
slightly aggravated	1 0.9%
somewhat aggravated	2 1.9%

9. Secondary Outcome

Title	European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Description	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.

Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
Measure Participants	106
Day 1: Trouble in strenuous activities (n=106)	3.00 (0.79)
Day 15: Trouble in strenuous activities (n=106)	3.07 (0.84)
Day 1: Trouble in long walk (n=106)	2.98 (0.78)
Day 15: Trouble in long walk (n=106)	3.18 (0.79)
Day 1: Trouble in short walk outside house (n=106)	1.98 (0.93)
Day 15: Trouble in short walk outside house(n=106)	2.22 (0.99)
Day 1: Stay in bed/chair (n=106)	2.64 (0.83)
Day 15: Stay in bed/chair (n=106)	2.71 (0.78)
Day 1: Need help in usual activities (n=106)	1.56 (0.84)
Day 15: Need help in usual activities (n=106)	1.72 (0.95)
Day 1: Limitation in work/other activites (n=106)	2.58 (0.81)
Day 15: Limitation in work/other activites (n=106)	2.66 (0.84)
Day 1:Limitation-hobbies/leisure activites(n=106)	2.56 (0.85)
Day 15:Limitation-hobbies/leisure activites(n=106)	2.61 (0.85)
Day 1: Short of breath (n=106)	2.02 (0.86)
Day 15: Short of breath (n=106)	2.04 (0.87)
Day 1: Had pain (n=106)	2.90 (0.74)
Day 15: Had pain (n=106)	2.66 (0.79)
Day 1: Needs rest (n=105)	2.74 (0.81)
Day 15: Needs rest (n=105)	2.78 (0.75)
Day 1: Trouble in sleeping (n=106)	2.18 (0.90)
Day 15: Trouble in sleeping (n=106)	2.13 (0.87)
Day 1: Felt weak (n=106)	2.50 (0.77)
Day 15: Felt weak (n=106)	2.52 (0.78)
Day 1: Apetite loss (n=106)	2.27 (0.91)
Day 15: Apetite loss (n=106)	2.41 (0.94)
Day 1: Felt nauseated (n=106)	1.75 (0.83)
Day 15: Felt nauseated (n=106)	1.85 (0.90)
Day 1: Vomitting (n=106)	1.29 (0.53)
Day 15: Vomitting (n=106)	1.24 (0.51)
Day 1: Constipation (n=106)	2.15 (0.99)
Day 15: Constipation (n=106)	2.08 (0.96)
Day 1: Diarrhea (n=106)	1.34 (0.65)
Day 15: Diarrhea (n=106)	1.18 (0.47)
Day 1: Tired (n=106)	2.62 (0.79)
Day 15: Tired (n=106)	2.51 (0.78)
Day 1:Pain interference - daily activities(n=106)	2.69 (0.85)
Day 15:Pain interference - daily activities(n=106)	2.60 (0.81)
Day 1: Difficulty in concentrating (n=106)	2.10 (0.84)
Day 15: Difficulty in concentrating (n=106)	2.13 (0.85)
Day 1: Felt tensed (n=106)	1.95 (0.76)
Day 15: Felt tensed (n=106)	2.01 (0.77)
Day 1: Worried (n=106)	2.12 (0.78)
Day 15: Worried (n=106)	2.16 (0.81)
Day 1: Felt irritated (n=106)	2.22 (0.83)
Day 15: Felt irritated (n=106)	2.20 (0.86)
Day 1: Felt depressed (n=106)	2.07 (0.82)
Day 15: Felt depressed (n=106)	1.94 (0.88)
Day 1: Difficulty in remembering (n=104)	2.02 (0.87)
Day 15: Difficulty in remembering (n=104)	1.95 (0.84)
Day 1: Interference in family life (n=106)	2.47 (0.88)
Day 15: Interference in family life (n=106)	2.59 (0.87)
Day 1: Interference in social life (n=106)	2.58 (0.88)
Day 15: Interference in social life (n=106)	2.60 (0.90)
Day 1: Economical difficulties (n=106)	2.58 (0.82)
Day 15: Economical difficulties (n=106)	2.51 (0.81)
Day 1: Global health status (n=106)	3.42 (1.01)
Day 15: Global health status (n=106)	3.42 (1.15)
Day 1: Quality of life (n=106)	3.47 (1.04)
Day 15: Quality of life (n=106)	3.44 (1.08)

Adverse Events

Time Frame	Baseline up to Day 15
Adverse Event Reporting Description	Safety population included 107 participants who administered the study drug more than once and were considered to have data for safety analysis.
Arm/Group Title	Hydromorphone HCl OROS
Arm/Group Description	Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
All Cause Mortality
	Hydromorphone HCl OROS
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hydromorphone HCl OROS
	Affected / at Risk (%)	# Events
Total	33/107 (30.8%)
Blood and lymphatic system disorders
Neutropenia	1/107 (0.9%)
Gastrointestinal disorders
Mallory-weisssyndrome	1/107 (0.9%)
Stomatitis	1/107 (0.9%)
General disorders
Asthenia	7/107 (6.5%)
Disease progression	5/107 (4.7%)
Fatigue	2/107 (1.9%)
Death	1/107 (0.9%)
Infections and infestations
Pneumonia	1/107 (0.9%)
Septic shock	1/107 (0.9%)
Metabolism and nutrition disorders
Anorexia	1/107 (0.9%)
Decreased appetite	1/107 (0.9%)
Hyperglycemia	1/107 (0.9%)
Musculoskeletal and connective tissue disorders
Back pain	1/107 (0.9%)
Osteoporotic fracture	1/107 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	6/106 (5.7%)
Lung neoplasm malignant	5/107 (4.7%)
Breast cancer	1/107 (0.9%)
Metastases tobone	1/107 (0.9%)
Pancreatic carcinoma	1/107 (0.9%)
Tonsil cancer	1/107 (0.9%)
Nervous system disorders
Comahepatic	1/107 (0.9%)
Psychiatric disorders
Confusional state	1/107 (0.9%)
Respiratory, thoracic and mediastinal disorders
Hemoptysis	1/107 (0.9%)
Pleural effusion	1/107 (0.9%)
Pneumonia aspiration	1/107 (0.9%)
Other (Not Including Serious) Adverse Events
	Hydromorphone HCl OROS
	Affected / at Risk (%)	# Events
Total	95/107 (88.8%)
Gastrointestinal disorders
Constipation	55/107 (51.4%)	61
Nausea	34/107 (31.8%)	36
Vomiting	25/107 (23.4%)	28
Diarrhoea	12/107 (11.2%)	13
General disorders
Asthenia	43/107 (40.2%)	45
Nervous system disorders
Dizziness	45/107 (42.1%)	53
Respiratory, thoracic and mediastinal disorders
Dyspnoea	25/107 (23.4%)	30
Skin and subcutaneous tissue disorders
Pruritus	6/107 (5.6%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.