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

This study has been terminated.
(the study was stopped due to non-availability of 4mg)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01648699
First received: July 20, 2012
Last updated: October 1, 2013
Last verified: October 2013

July 20, 2012
October 1, 2013
April 2010
September 2010   (final data collection date for primary outcome measure)
  • Brief Pain Inventory (BPI) Average Score at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Change in Brief Pain Inventory (BPI) Average Score from Baseline [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
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).
Complete list of historical versions of study NCT01648699 on ClinicalTrials.gov Archive Site
  • Number of Participants Given Rescue Pain Medications [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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).
  • Number of Patients Given Rescue Pain Medications [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of change per visit, from "very much worse" to "very much improved".
  • Incidence of Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of discontinuation due to Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Osmotic Release Oral System (OROS) hydromorphone
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.
Other Name: Jumista
Experimental: Osmotic Release Oral System (OROS) Hydromorphone
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.
Intervention: Drug: Osmotic Release Oral System (OROS) hydromorphone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01648699
CR016351, 42801PAI4008
No
Janssen Pharmaceutica
Janssen Pharmaceutica
Not Provided
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
Janssen Pharmaceutica
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP