PainPhase 4NCT01648699

Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain

A Phase 4 study testing Osmotic Release Oral System (OROS) hydromorphone in people with Pain, run by Janssen Pharmaceutica.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Pain
What is being tested?: Osmotic Release Oral System (OROS) hydromorphone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Apr 2010to Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant with histological confirmed malignancy
Participant on stable morphine or 25 milligram oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day
Life expectancy of at least 3 months
Negative urine pregnancy test
Participants with signed informed consent

Who cannot join

Participant intolerant or hypersensitive to hydromorphone or other opioid agonist
Participant with unstable medical condition
Participant with renal dysfunction and liver dysfunction
Participant dependence to opiates
Inability to take oral medication

About this study

Official title: Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain

Read the detailed description

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

Conditions: Pain
Being tested: Osmotic Release Oral System (OROS) hydromorphone
Keywords: Pain, Cancer, Osmotic Release Oral System, OROS Hydromorphone, Jurnista
Medical subject headings: Pain, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Osmotic Release Oral System (OROS) hydromorphoneDrug
Also called Jumista
OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.

Study groups in NCT01648699
Study group	Role	What they receive
Osmotic Release Oral System (OROS) Hydromorphone	Experimental	OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days. Receives: Drug: Osmotic Release Oral System (OROS) hydromorphone

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Pain Inventory (BPI) Average Score at Baseline
The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Measured: Baseline
Brief Pain Inventory (BPI) Average Score at Day 28
The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Measured: Day 28

Secondary outcomes (2)

Number of Participants Given Rescue Pain Medications
Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.
Measured: Day 28
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from "very much worse" to "very much improved" (as compared to Baseline).
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Sep 2010

First posted24 Jul 2012 (estimated)
Study startApr 2010
Primary completionSep 2010
Study completionSep 2010

Why it stopped: the study was stopped due to non-availability of 4mg

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01648699
Sponsor's protocol ID: CR016351
Other IDs: 42801PAI4008
Status last verified: Oct 2013
First submitted: 20 Jul 2012
Last updated: 11 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain
ClinicalTrials.gov ID: NCT01648699
Acronym / sponsor ID: CR016351
Conditions: Pain
Keywords: Pain, Cancer, Osmotic Release Oral System, OROS Hydromorphone, Jurnista
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: the study was stopped due to non-availability of 4mg
Enrolment: 20 participants (actual)
Lead sponsor: Janssen PharmaceuticaIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 24 Jul 2012 (estimated)
Results: Posted 11 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Osmotic Release Oral System (OROS) Hydromorphone	Experimental	Drug: Osmotic Release Oral System (OROS) hydromorphoneOROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant with histological confirmed malignancy
Participant on stable morphine or 25 milligram oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day
Life expectancy of at least 3 months
Negative urine pregnancy test
Participants with signed informed consent

Key exclusion criteria (5 listed)

Participant intolerant or hypersensitive to hydromorphone or other opioid agonist
Participant with unstable medical condition
Participant with renal dysfunction and liver dysfunction
Participant dependence to opiates
Inability to take oral medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Osmotic Release Oral System (OROS) hydromorphoneAlso: JumistaOROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.	Drug	Osmotic Release Oral System (OROS) Hydromorphone

Primary outcome

Brief Pain Inventory (BPI) Average Score at Baseline
Time frame: Baseline
The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Brief Pain Inventory (BPI) Average Score at Day 28
Time frame: Day 28
The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.

2 secondary outcomes

Number of Participants Given Rescue Pain Medications
Time frame: Day 28
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Time frame: Day 28

Results and safety

Results posted to the registry on 11 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Osmotic Release Oral System (OROS) Hydromorphone	20	15

Primary outcome: Brief Pain Inventory (BPI) Average Score at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: Units on a scale

Measure	OROS Hydromorphone 8 Milligram (mg) n = 5	OROS Hydromorphone 12 mg n = 6	OROS Hydromorphone 16 mg n = 3	OROS Hydromorphone 20 mg n = 2	OROS Hydromorphone 24 mg n = 1	OROS Hydromorphone 32 mg n = 1	OROS Hydromorphone 36 mg n = 2
Severity item: Worst pain in last 24 hours	7.40 (1.82)	6.50 (3.45)	4.00 (4.00)	10.00 (0.00)	2.00 (0.00)	8.0 (0.00)	5.0 (2.83)
Severity item: Least pain in last 24 hours	2.60 (2.70)	1.00 (1.67)	1.00 (1.73)	3.00 (1.41)	0.00 (0.00)	3.0 (0.00)	3.5 (4.95)
Severity item: Average pain	5.50 (2.78)	2.50 (1.97)	3.00 (2.65)	5.50 (0.71)	1.00 (0.00)	5.0 (0.00)	3.5 (4.95)
Severity item: Pain right now	4.60 (4.03)	2.00 (2.28)	2.67 (3.06)	7.00 (4.24)	4.00 (0.00)	3.0 (0.00)	5.0 (4.24)
Interference item: General activity	6.20 (4.27)	4.50 (3.39)	4.33 (3.79)	6.50 (2.12)	0.00 (0.00)	8.0 (0.00)	7.0 (1.41)
Interference item: Mood	7.00 (1.87)	3.00 (2.37)	5.33 (4.73)	6.00 (1.41)	5.00 (0.00)	7.00 (0.00)	6.00 (1.41)
Interference item: Walking ability	7.40 (1.82)	4.17 (4.22)	5.33 (4.62)	8.00 (2.83)	3.00 (0.00)	7.00 (0.00)	6.50 (0.71)
Interference item: Normal work	5.00 (3.61)	5.83 (4.12)	6.33 (5.51)	9.00 (1.41)	0.00 (0.00)	9.00 (0.00)	9.00 (1.41)

Population analysed: Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.

Primary outcome: Brief Pain Inventory (BPI) Average Score at Day 28

Time frame: Day 28. Mean (Standard Deviation). Unit: Units on a scale

Measure	OROS Hydromorphone 8 Milligram (mg) n = 1	OROS Hydromorphone 12 mg n = 5	OROS Hydromorphone 20 mg n = 2	OROS Hydromorphone 24 mg n = 1	OROS Hydromorphone 32 mg n = 3	OROS Hydromorphone 40 mg n = 1
Severity item: Worst pain in last 24 hours	2.00 (0.00)	3.20 (3.35)	4.00 (5.66)	4.00 (0.00)	7.00 (3.61)	7.00 (0.00)
Severity item: Least pain in last 24 hours	0.00 (0.00)	2.40 (3.05)	1.50 (2.12)	0.00 (0.00)	3.67 (4.04)	3.00 (0.00)
Severity item: Average pain	2.00 (0.00)	2.40 (3.21)	1.50 (2.12)	0.00 (0.00)	5.33 (3.06)	4.00 (0.00)
Severity item: Pain right now	2.00 (0.00)	1.00 (2.24)	0.00 (0.00)	0.00 (0.00)	6.67 (4.04)	3.00 (0.00)
Interference item: General activity	2.00 (0.00)	4.20 (4.60)	5.00 (7.07)	0.00 (0.00)	7.33 (4.62)	7.00 (0.00)
Interference item: Mood	2.00 (0.00)	1.80 (3.03)	5.00 (7.07)	0.00 (0.00)	4.67 (2.89)	7.00 (0.00)
Interference item: Talking ability	0.00 (0.00)	4.00 (4.69)	5.00 (7.07)	0.00 (0.00)	8.00 (3.46)	7.00 (0.00)
Interference item: Normal work	2.00 (0.00)	3.20 (4.32)	5.00 (7.07)	0.00 (0.00)	8.00 (3.46)	7.00 (0.00)

Population analysed: ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 28. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OROS Hydromorphone	2 of 20 (10%)	9 of 20 (45%)	Not reported

Limitations and caveats (from the sponsor): The study was prematurely terminated due to administrative reason.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Pharmaceutica Clinical Trial study director

Janssen Pharmaceutica

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Osmotic Release Oral System (OROS) hydromorphone in people with Pain, run by Janssen Pharmaceutica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory (BPI) Average Score at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01648699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.