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

NCT ID: NCT00261495

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

Brief 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).

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxycodone

Group Type: ACTIVE_COMPARATOR

Oxycodone

Intervention Type: DRUG

10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)

OROS hydromorphone HCl

Group Type: EXPERIMENTAL

OROS hydromorphone HCl

Intervention Type: DRUG

8 to 32 mg once daily for 52 weeks (flexible dosing)

Interventions

OROS hydromorphone HCl

8 to 32 mg once daily for 52 weeks (flexible dosing)

Intervention Type: DRUG

Oxycodone

10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Locations

Brno, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Copenhagen, , Denmark

Esbjerg, , Denmark

Nyborg, , Denmark

Svendborg, , Denmark

Vejle, , Denmark

Amiens, , 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

Nuremberg, , Germany

Regensburg, , Germany

Rodgau, , Germany

Wiesbaden, , Germany

Bodø, , Norway

Lørenskog, , Norway

Oslo, , Norway

Gdansk, , Poland

Krakow, , Poland

Lublin, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Martin, , Slovakia

Prešov, , Slovakia

Ljubljana, , Slovenia

Maribor, , Slovenia

Slovenj Gradec, , Slovenia

Gothenburg, , Sweden

Jönköping, , Sweden

Kristianstad, , Sweden

Linköping, , Sweden

Aarau, , Switzerland

Basel, , Switzerland

Lausanne, , Switzerland

Countries

Czechia; Denmark; France; Germany; Norway; Poland; Slovakia; Slovenia; Sweden; Switzerland

References

Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS((R)) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010 Sep-Oct;10(5):404-15. doi: 10.1111/j.1533-2500.2009.00342.x.

Reference Type: RESULT

PMID: 20384968 (View on PubMed)

Other Identifiers

OROS-ANA-3001

Identifier Type: OTHER

Identifier Source: secondary_id

2004-005187-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR002374

Identifier Type: -

Identifier Source: org_study_id