NCT00398788

Brief Summary

The purpose of the study was to characterize the safety, effectiveness, and impact on quality of life (QOL) measures of OROS® hydromorphone HCL 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 P50-P75 for phase_2 low-back-pain

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

November 10, 2006

Last Update Submit

April 26, 2010

Conditions

Low Back Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;

Secondary Outcomes (1)

  • The overall global evaluation and Brief Pain Inventory (BPI) of study drug, as assessed by both patients and Investigators at weekly visits during the 4 week maintenance phase.

Interventions

OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patient with chronic low back pain who were currently receiving strong oral or transdermal opioid analgesics on a daily basis, or patients suitable for advancement of therapy to step 3 of the World Health Organization (WHO) analgesic ladder were considered for enrollment in the study. Patients requiring \>8 and =96 mg of OROS® hydromorphone HCL every 24 hours were enrolled in the study.

You may not qualify if:

  • Patients intolerant or hypersensitive to hydromorphone or other opioid agonists and patients with a known history of alcohol or drug abuse within the previous year were excluded from study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wallace M, Skowronski R, Khanna S, Tudor IC, Thipphawong J. Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). Curr Med Res Opin. 2007 May;23(5):981-9. doi: 10.1185/030079907x182040.

    PMID: 17519065RESULT

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Completion

November 1, 2001

Last Updated

April 27, 2010

Record last verified: 2010-04