NCT00347685

Brief Summary

The purpose of this study is to assess the safety of tramadol HCl ER following long-term treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and effective for the treatment of chronic, non-malignant pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for phase_3 chronic-pain

Timeline
Completed

Started Oct 2000

Typical duration for phase_3 chronic-pain

Geographic Reach
1 country

1 active site

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

October 1, 2000

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2006

Completed
3 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 1, 2006

Last Update Submit

June 20, 2012

Conditions

Chronic Pain

Keywords

chronic non-malignant pain; chronic pain; non-malignantpain; moderate pain; severe pain

Outcome Measures

Primary Outcomes (2)

  • The primary outcomes are analyses of adverse events (incidence, frequency,

  • severity, attribution, adverse events causing withdrawal from study)

Secondary Outcomes (3)

  • The secondary outcomes are pain intensity (visual analog scale) assessment,

  • patient global assessment of study medication, pain recall (least, worst and

  • average pain); changes from baseline to each subsequent visit.

Interventions

tramadol ERDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with a history of chronic, non-malignant pain \>= 6 months requiring treatment with an analgesic; females of childbearing potential practicing abstinence or a medically accepted form of contraception with a negative serum pregnancy test within 7 days of study entry; patients able to understand the procedures, complete the pain scales and able to communicate meaningfully with study personnel; patients who agree to study participation and sign a form indicating their informed consent.

You may not qualify if:

  • Patients with an uncontrolled medical condition; patients whose weight \<= 100 pounds; patients with dysphagia or difficulty swallowing tablets; patients with intractable nausea and vomiting; patients with a history of clinically significant intolerance to tramadol or a known hypersensitivity to opioid analgesics, such that treatment with tramadol or other opioids is contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gainesville Clinical Research Center

Gainesville, Florida, 32605, United States

Location

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 1, 2006

First Posted

July 4, 2006

Study Start

October 1, 2000

Study Completion

February 1, 2003

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

US(1)