Trial Outcomes & Findings for Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee (NCT NCT00980798)

Last Updated: 2014-04-25

Results Overview

The analgesic effect was assessed by the BPI item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine".

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

288 participants

Primary outcome timeframe

At each study visit from screening to week 16

Results posted on

2014-04-25

Participant Flow

The first subject attended the first study visit on 05 October 2007, and the last subject completed the last study visit on 24 November 2008.

Participant milestones

Participant milestones
Measure	Placebo Placebo daily for 16 weeks	OROS Hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks
Overall Study STARTED	149	139
Overall Study COMPLETED	116	84
Overall Study NOT COMPLETED	33	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo daily for 16 weeks	OROS Hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks
Overall Study Adverse Event	7	36
Overall Study Lack of Efficacy	16	5
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	2	1
Overall Study Withdrawal by Subject	8	11
Overall Study Other	0	1

Baseline Characteristics

Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=149 Participants Placebo daily for 16 weeks	OROS Hydromorphone HCl n=139 Participants 4 to 32 mg taken orally once daily for 16 weeks	Total n=288 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 10.37 • n=99 Participants	65.1 years STANDARD_DEVIATION 9.96 • n=107 Participants	65 years STANDARD_DEVIATION 10.16 • n=206 Participants
Sex: Female, Male Female	101 Participants n=99 Participants	107 Participants n=107 Participants	208 Participants n=206 Participants
Sex: Female, Male Male	48 Participants n=99 Participants	32 Participants n=107 Participants	80 Participants n=206 Participants

PRIMARY outcome

Timeframe: At each study visit from screening to week 16

Population: The primary population for the efficacy analyses was the intention to treat (ITT) population: all randomised patients who received at least one dose of study drug excluding patients who had no post-baseline efficacy data. This population included patients who discontinued early owing to lack of efficacy or other reasons.

The analgesic effect was assessed by the BPI item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine".

Outcome measures

Outcome measures
Measure	Placebo n=143 Participants Placebo daily for 16 weeks	OROS Hydromorphone HCl n=132 Participants 4 to 32 mg taken orally once daily for 16 weeks
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Screening	6.4 units on a scale Standard Deviation 0.94	6.4 units on a scale Standard Deviation 1.05
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Baseline (Visit 1)	6.5 units on a scale Standard Deviation 0.94	6.6 units on a scale Standard Deviation 1.04
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 2	5.2 units on a scale Standard Deviation 1.43	5.0 units on a scale Standard Deviation 1.63
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 3	4.8 units on a scale Standard Deviation 1.66	4.6 units on a scale Standard Deviation 1.66
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 4	4.3 units on a scale Standard Deviation 1.72	4.0 units on a scale Standard Deviation 1.85
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 5	3.9 units on a scale Standard Deviation 1.9	3.9 units on a scale Standard Deviation 2.02
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 6	3.7 units on a scale Standard Deviation 1.97	3.5 units on a scale Standard Deviation 1.88
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 7	3.6 units on a scale Standard Deviation 1.99	3.4 units on a scale Standard Deviation 1.96
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 8	4.0 units on a scale Standard Deviation 2.3	4.1 units on a scale Standard Deviation 2.2
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) Visit 9	4.2 units on a scale Standard Deviation 2.27	4.4 units on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: At each study visit from baseline until week 16

Population: Safety population: All randomised patients who received at least one dose of study drug.

The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Placebo daily for 16 weeks	OROS Hydromorphone HCl n=139 Participants 4 to 32 mg taken orally once daily for 16 weeks
The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event	7 participants	36 participants

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 50 other events

Deaths: 0 deaths

OROS Hydromorphone HCl

Serious events: 4 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=149 participants at risk Placebo daily for 16 weeks	OROS Hydromorphone HCl n=139 participants at risk 4 to 32 mg taken orally once daily for 16 weeks
Gastrointestinal disorders Constipation	6.7% 10/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	45.3% 63/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Gastrointestinal disorders Nausea	6.7% 10/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	29.5% 41/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Gastrointestinal disorders Vomiting	1.3% 2/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	10.8% 15/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Gastrointestinal disorders Dry mouth	4.7% 7/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	7.9% 11/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Nervous system disorders Somnolence	14.8% 22/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	32.4% 45/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Nervous system disorders Dizziness	3.4% 5/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	10.8% 15/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Nervous system disorders Headache	2.7% 4/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	5.8% 8/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Skin and subcutaneous tissue disorders Pruritus	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	7.2% 10/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	5.0% 7/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Ear and labyrinth disorders Vertigo	2.7% 4/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	7.2% 10/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Metabolism and nutrition disorders Anorexia	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	5.8% 8/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)

Additional Information

EMEA Medical Affairs Director Analgesia

Janssen-Cilag Ireland

Phone: 0035 878 339174

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo n=149 participants at risk Placebo daily for 16 weeks	OROS Hydromorphone HCl n=139 participants at risk 4 to 32 mg taken orally once daily for 16 weeks
Gastrointestinal disorders Dyspepsia	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	1.4% 2/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Gastrointestinal disorders Diarrhoea	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Gastrointestinal disorders Nausea	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
General disorders Asthenia	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Injury, poisoning and procedural complications Skin laceration	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Injury, poisoning and procedural complications Road traffic accident	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Nervous system disorders Cerebrovascular accident	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Vascular disorders Hypertensive crisis	0.00% 0/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.72% 1/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Cardiac disorders Atrial fibrillation	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Cardiac disorders Myocardial infarction	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Cardiac disorders Supraventricular tachycardia	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Infections and infestations Pyelonephritis acute	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Metabolism and nutrition disorders Hyperglycaemia	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Skin and subcutaneous tissue disorders Dermatitis allergic	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
Surgical and medical procedures Cardioversion	0.67% 1/149 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)	0.00% 0/139 • Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)