NCT00411268

Brief Summary

The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P25-P50 for phase_3 low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

December 12, 2006

Last Update Submit

April 26, 2010

Conditions

Low Back Pain

Keywords

Chronic low back painOROS hydromorphone slow release tabletQuality of Life

Outcome Measures

Primary Outcomes (1)

  • The daily pain relief rating obtained during the study.(six months)

Secondary Outcomes (1)

  • Differences from first visit to each subsequent visit in Brief Pain Inventory (BPI) ratings, sleep scores and quality of life questionnaires.

Interventions

OROS hydromorphone HCI SR (slow release)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
  • Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
  • Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release

You may not qualify if:

  • Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
  • Patients who are pregnant or breast-feeding
  • Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
  • Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
  • Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Completion

June 1, 2001

Last Updated

April 27, 2010

Record last verified: 2010-04