NCT00347724

Brief Summary

The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain requiring daily analgesic treatment. The study hypothesis is that tramadol ER is effective in the treatment of moderate to severe chronic low back pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3 chronic-pain

Timeline
Completed

Started Nov 2000

Shorter than P25 for phase_3 chronic-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 Start

First participant enrolled

November 1, 2000

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

First QC Date

July 2, 2006

Last Update Submit

June 20, 2012

Conditions

Chronic Pain

Keywords

chronic low back pain; chronic pain; low back pain; extended-release analgesia; opioid

Outcome Measures

Primary Outcomes (1)

  • Patient's pain intensity score since the previous visit,using a visual analog scale(VAS) where 0 mm = no pain and 100 mm = extreme pain.

Secondary Outcomes (4)

  • Patient's current pain intensity VAS score

  • Patient's global assessment

  • Roland Disability Index

  • Patient's sleep assessment

Interventions

Tramadol HCl ERDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a history of chronic low back pain \>= 6 months requiring treatment with NSAIDs, acetaminophen, opioid analgesics, COX-2 selective inhibitors, and/or muscle relaxants for at least 60 of the 90 days preceeding the screening visit; in good health as determined by the investigator on the basis of medical history, physical exam and screening labs; patient's low back pain intensity measures \>= 40 mm on a visual analog scale (VAS) at the start of the run-in peroid after the 2-7 day washout; patients who are able to discontinue treatment with NSAIDs, COX-2 selective inhibitors, tramadol, muscle relaxants, opioids, and/or other analgesics during the 2-7 day washout period and all other analgesics throughout the entire study.

You may not qualify if:

  • Patients with a diagnosis of a complex regional pain syndrome, significant inflammatory pain, or clinically significant active fibromyalgia; patients with a history of lumbar surgery or chemonucleolysis; patients undergoing transcutaneous electrical nerve stimulation (TENS) or spinal manipulation for low back pain; patients with an uncontrolled medical condition or a clinically significant condition that would, in the investigator's opinion, preclude study participation; patients using analgesics or other agents during washout that could confound the analgesic response.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2006

First Posted

July 4, 2006

Study Start

November 1, 2000

Study Completion

November 1, 2001

Last Updated

June 21, 2012

Record last verified: 2012-06