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

NCT00980798 | Completed Phase 3 Results

• 2 other identifiers: CR012601HOP Trial
• Study Type: interventional
• Target: 288
• Locations: 4 countries
• Sites: 12

Brief Summary

This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured.

Conditions

Pain; Osteoarthritis, Hip; Osteoarthritis, Knee

Keywords

Osteoarthritis; Strong pain killer; Strong opioid; Low starting dose; Fewer side effects; Physical functioning; Pain control; Quality of life; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)

  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".

  At each study visit from screening to week 16

Secondary Outcomes (1)

• The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event

  At each study visit from baseline until week 16

Study Arms (2)

001

EXPERIMENTAL

OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks

Drug: OROS hydromorphone HCl

002

PLACEBO COMPARATOR

Placebo placebo tablet once daily for 16 weeks

Drug: Placebo

Interventions

OROS hydromorphone HCl DRUG

4 to 32 mg taken orally once daily for 16 weeks

001

Placebo DRUG

placebo tablet once daily for 16 weeks

002

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented Osteoarthritis of the hip or knee
• Chronic pain for more than 3 months treated with daily analgesic for the last month
• Moderate to severe OA pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
• Moderate to severe pain by means of a mean weekly score of \>= 5 in the Brief Pain Invetory item 5 'pain on average'

You may not qualify if:

• Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
• Diagnosis of major depression
• Treatment for epilepsy
• Corticosteroid injection within the last 3 months
• Major surgery in the 3 months before the start of the study
• Women who are pregnant or breast-feeding

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (12)

Unknown Facility

Klatovy, Czechia

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Pelhøimov, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Roudnice nad Labem, Czechia

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Cluj-Napoca, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Bratislava, Slovakia

Location

Unknown Facility

Hlohovec, Slovakia

Location

Unknown Facility

Piešťany, Slovakia

Location

Unknown Facility

London, United Kingdom

Location

Related Links

• Placebo-controlled trial with OROS hydromorphone hydrochloride to treat patients with moderate to severe pain induced by osteoarthritis of the hip or the knee.

MeSH Terms

Conditions

Pain; Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis; Agnosia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Limitations and Caveats

Concomitant and rescue medication were permitted in the study. This may be why the results in the placebo arm so closely resemble those in the treatment arm. Patients were also less severely impacted by the underlying disease than in other studies.

Results Point of Contact

• Title: EMEA Medical Affairs Director Analgesia
• Organization: Janssen-Cilag Ireland

0035 878 339174

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: October 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 25, 2014
• Results First Posted: September 6, 2010

Record last verified: 2014-04

Locations

GB (1); CZ (5); SL (3); RO (3)