A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

Chronic Pain Clinical Trial

Official title:

A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631319
• Other study ID #: NMT 1077-302
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria

• Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months

• Patients required daily opioid medication to treat their chronic osteoarthritis pain

Exclusion Criteria

• Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain

• History drug or alcohol abuse

• Fibromyalgia

• Patients who have major depression or anxiety

• Women who are pregnant or breast feeding

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

Intervention

Drug:
• OROS hydromorphone
hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase		Baseline to Week 12
Other	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase		Baseline to Week 12
Other	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase		Baseline to Week 12
Other	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase		Baseline to Week 12
Other	Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase		Baseline to Week 12
Other	Time to Treatment Failure From Baseline		within 12 weeks from Baseline
Primary	Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase	Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.	Baseline, Week 12