DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: OROS hydromorphone HCl (Drug); Oxycodone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Pharmaceutica N.V., Belgium

Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V.

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).

Clinical Details

Official title: Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)

Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)

Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)

Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)

Equi-analgesic Dose at Steady-state (PP Population)

Equi-analgesic Dose at Steady State (ITT Population)

Secondary outcome:

Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)

Change From Baseline in Sleep Quality at Week 24

Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24

Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24

Number of Subjects With Dose Escalation

Change From Baseline in BPI Severity Score "Pain Right Now" (BPI Item 6) at Week 4

Change From Baseline in BPI Pain Severity Score "Pain at Its Least" (BPI Item 4) at Week 4

Change From Baseline in BPI Pain Severity "Pain at Its Worst" (BPI Item 3) at Week 4

Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 4

Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4

Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4

Change From Baseline in BPI Pain Severity "Pain at Its Least" (BPI Item 4) at Week 24

Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 24

Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24

Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24

Change From Baseline in BPI Interference Score "Interfered With General Activity" (BPI Item 9a) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 4

Change From Baseline in Pain Interference "Pain Interfered With General Activity" (BPI Item 9a) at Week 24

Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 24

Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 24

Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 24

Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 24

Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 24

Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 24

Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)

Change From Baseline in Sleep Quality (MOS Index I) at Week 4

Change From Baseline in Sleep Quality (MOS Index II) at Week 4

Change From Baseline in Sleep Quality (MOS Index II) at Week 24

Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24

Change From Baseline in Sleep Quality, Snoring at Week 24

Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24

Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24

Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24

Change From Baseline in Sleep Quality, Sleep Quantity at Week 24

Number of Subjects Indicating That They Had Optimal Sleep at Week 24

Change From Baseline in Sleep Quality at Week 52

Number of Subjects Indicating Optimal Sleep at Week 52

Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24

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

Number of Subjects With Dose Escalation at Week 4 (ITT Population)

Number of Subjects With Dose Escalation at Week 24 (ITT Population)

Change From Baseline in Quality of Life (QoL) "Bodily Pain" at Week 4

Change From Baseline in QoL "General Health Perceptions" at Week 4

Change From Baseline in QoL "Health Transition" at Week 4

Change From Baseline in QoL "Mental Health" at Week 4

Change From Baseline in QoL "Physical Functioning" at Week 4

Change From Baseline in QoL "Role Emotional" at Week 4

Change From Baseline in QoL "Role Physical" at Week 4

Change From Baseline in QoL "Social Functioning" at Week 4

Change From Baseline in QoL "Vitality" at Week 4

Change From Baseline in QoL "Bodily Pain" at Week 24

Change From Baseline in QoL "General Health Perceptions" at Week 24

Change From Baseline in QoL "Health Transition" at Week 24

Change From Baseline in QoL "Mental Health" at Week 24

Change From Baseline in QoL "Physical Functioning" at Week 24

Change From Baseline in QoL "Role Emotional" at Week 24

Change From Baseline in QoL "Role Physical" at Week 24

Change From Baseline in QoL "Social Functioning" at Week 24

Change From Baseline in QoL "Vitality" at Week 24

Change From Baseline in QoL at Week 52

Clinical Global Assessment of Efficacy

Change in Dose of Study Treatment

Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)

Number of Drop-outs

Number of Days With add-on Pain Medication

Amount of add-on Pain Medication

Mode and Convenience of Drug Intake.

Resource Utilization of Pain Management

Detailed description: Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short duration of action that require dosing every 4 to 6 hours. To counterbalance the drawback of repeated opioid intake, sustained-release formulations of oxycodone and hydromorphone were developed that allow twice-daily dosing. Subsequently, a novel, once-daily, extended-release hydromorphone formulation was developed to further enhance ease of treatment and improve effectiveness in the treatment of severe pain. This is a randomized, open-label, comparative, parallel-group, 24-week flexible-dose study in patients with chronic noncancer pain severe enough to require continuous opioid therapy. Patients will receive either 8 mg of sustained-release hydromorphone, taken once daily or 10 mg of controlled-release oxycodone, taken twice daily. Individual adjustments in dosing will be performed to achieve satisfactory pain control, up to a maximum daily dosage of 32 mg for hydromorphone and 80 mg for oxycodone. The primary efficacy outcome will be the determination of the dose of hydromorphone that produces a level of pain control that is equal to the pain control provided by oxycodone (equi-analgesic dose). Safety will be monitored throughout the study. The study hypothesis is that sustained-release hydromorphone taken once daily is well tolerated and is not inferior with regard to pain control to controlled-release oxycodone taken twice daily. Amendment: Amendment was made to the duration of the study from duration of '24 weeks' to '52 weeks' in order to collect long-term safety and efficacy data. OROS hydromorphone 8, 16, or 32 mg tablets QD or SR oxycodone 10, 20, or 40 mg tablets BID. Individual adjustments in dosing performed to achieve satisfactory pain control over 24 weeks. Amendment: treatment duration was extended to 52 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Brno, Czech Republic

Plzen, Czech Republic

Praha 5, Czech Republic

Praha 8, Czech Republic

Esbjerg N/A, Denmark

København, Denmark

Nyborg N/A, Denmark

Svendborg N/A, Denmark

Vejle, Denmark

Amiens Cedex 1, France

Bois Guillaume, France

Lille, France

Paris, France

Berlin, Germany

Drensteinfurt, Germany

Dresden, Germany

Duderstadt, Germany

Frankfurt, Germany

Giessen, Germany

Göppingen, Germany

Hamburg, Germany

Herne, Germany

Jena, Germany

Kiel, Germany

Kÿln, Germany

Ludwigshafen, Germany

Mannheim, Germany

Nürnberg, Germany

Regensburg, Germany

Rodgau, Germany

Wiesbaden, Germany

Bodø, Norway

Lørenskog, Norway

Oslo N/A, Norway

Oslo, Norway

Gdansk, Poland

Krakow, Poland

Lublin, Poland

Warszawa, Poland

Wroclaw, Poland

Banska Bystrica, Slovakia

Bratislava, Slovakia

Martin, Slovakia

Prešov, Slovakia

Ljubljana, Slovenia

Maribor, Slovenia

Slovenj Gradec, Slovenia

Göteborg, Sweden

Jönköping, Sweden

Kristianstad, Sweden

Linköping, Sweden

Aarau, Switzerland

Basel, Switzerland

Lausanne, Switzerland

Additional Information

Starting date: March 2006
Last updated: May 21, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015