A Study to Evaluate the Safety and Effectiveness of Fentanyl-TTS Compared to Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDS (Non-steroidal Anti-inflammatory Drugs).

May 18, 2011 updated by: Janssen-Cilag, S.A.

Randomised Study to Evaluate the Efficacy and Safety of Fentanyl-TTS Versus Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDs (Non-steroidal Anti-inflammatory Drugs).

To show, using the analgesic WHO scale, that fentanyl-TTS may be directly used for treating moderate to severe cancer pain in patients treated with NSAIDs, acetaminophen, or metamizole (first step drugs) avoiding the second step, and may be at least as effective and safe as currently used second step drugs, minor opioids.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, randomized(study drug assigned by chance), open-label, nationwide study. Patients with moderate to severe chronic pain due to the oncological disease (VAS>5) meeting the inclusion and exclusion criteria were randomized to treatment with fentanyl-TTS (transdermal patches, initial dosage: 25µg/h patch every 3 days, experimental drug) or with minor opioids (Tramadol, initial dosage of 200mg/day and Dihydrocodeine initial dosage of 120mg/day, control arm). The follow-up and drug administration was two months, during which controls were performed every 7 days, except for the first that was on Day 4. If pain was not controlled (VAS<3), the investigator could increase the dose of the relevant drug (according to data sheet). The primary endpoint has been the control of pain during treatment. Pain was assessed by the visual analogue scale. Pain severity was assessed at each follow-up visit. The secondary endpoint was to assess the advantages of using fentanyl-TTS after the first step of the WHO analgesic ladder as compared to minor opioids. These advantages were assessed based on the incidence of side effects associated with treatment with opioids during treatment where the following was assessed by a table with the most common side effects: nausea, vomiting, constipation and drowsiness (WHO) and their severity, the quantity of support drugs required by the patients to cope with the side effects occurring, adverse events related to the study drug, and the percentage of patients discontinuing or switching treatment due to side effects. Fentanyl, dosage forms: 25µg/h, 50µg/h and 100µg/h. Transdermal patches (initial dosage: 25µg/h patch every 3 days). Tramadol, dosage forms: 100mg, 150mg and 200mg, (initial dosage: 200mg/day). Dihydrocodeine, dosage forms: 60mg, 90mg and 120mg, (initial dosage: 120mg/day). If pain was not controlled (VAS<3), the investigator could increase the dose of the relevant drug. The follow-up and drug administration was two months, during which controls were performed every 7 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with moderate to severe chronic pain due to the oncological condition, defined as VAS => 5, treated with first step drugs, either NSAIDs or acetaminophen or metamizole (the dose of first step drugs requiring a switch in treatment is left to the physician's discretion)
  • Patients with a documented histological diagnosis of cancer.

Exclusion Criteria:

  • Patients whose pain has some neuropathic component
  • Patients who have been treated with opioids during the 2 months prior to study entry
  • Patients with dermatological disease, a history of allergy or hypersensitivity to fentanyl or to adhesive components preventing use of patches
  • Patients with a history of cardiac, CNS, or respiratory disease that prevents their participation in the study in the investigator's judgment
  • Patients with kidney or liver failure contraindicating use of opioids based on medical criterion
  • Pregnant women or women of childbearing age who do not use an effective contraceptive method throughout the study
  • Patients in whom surgery is planned during the study
  • Patients who are participating at the same time in another trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
The primary endpoint was the control of pain during treatment. Pain was assessed by the visual analogue scale. Pain severity was assessed at each follow-up visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
The secondary endpoint was to assess the advantages of using fentanyl-TTS after the first step of the WHO analgesic ladder as compared to minor opioids.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR003526

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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