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CancerPhase 2NCT00236041

Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)

A Phase 2 study testing ACTIQ® in people with Cancer and Breakthrough Pain, run by Cephalon at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with cancer and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. Read more about this study

Who is it for?
Ages 3 to 15 years
Conditions the study is for
Cancer, Breakthrough Pain
What is being tested?
ACTIQ®
How many people
38 participants
Where
31 sitesin 2 countries
Study dates
Apr 2004to Aug 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent of the parent or legal guardian and patient assent, when appropriate, is obtained. (Lack of assent cannot be overturned.)
  • The child is aged 3 to under 16 years and weighs at least 15 kg.
  • The child must be using ATC opioid therapy for pain associated with cancer and be opioid-tolerant. NOTE: This requirement is defined as the patient receiving at least 1 mg/kg/day or 40 mg/day or more of oral morphine (or an equi-analgesic dosage of another opioid) or at least 25 mcg/hour of transdermal fentanyl for at least 7 days, (ATC opioid therapy may be administered as patient-controlled analgesia [PCA]).
  • The child must be experiencing episodes of BTP (defined as a transient flare of pain that requires a bolus of medication as treatment) as follows:
  • patients with cancer must be experiencing an average of at least 1 BTP episode a day.
  • patients with non-cancer related pain must be experiencing an average of 2 BTP episodes a day.
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  • The child has an average daily pain score of 6 or less (of 10) on the FPS-R.
  • Girls who are postmenarche or sexually active must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence.
  • The child, in the opinion of the investigator, is able to administer ACTIQ treatment effectively (ie, adequately moving the unit around in the mouth and sucking, not biting, the unit).
  • The child must be an inpatient.

Who cannot join

  • The child has pain uncontrolled by therapy, as determined by the investigator, that could adversely impact the safety of the patient or could be compromised by treatment with ACTIQ.
  • The child has known or suspected hypersensitivities/allergies or other contraindications to any ACTIQ component.
  • The child has received monoamine oxidase inhibitors (MAOIs) within 14 days before the first ACTIQ treatment.
  • The child has moderate to severe oral mucositis.
  • The child has a neuromuscular disease, significant renal impairment, or significant hepatic impairment as determined by the investigator.
  • The child has any other medical condition or is receiving concomitant medication/therapy that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise data collection.
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  • The child has received any experimental drug/therapy within 14 days of the first ACTIQ treatment. NOTE: Children may not be participating concurrently in another study when the other study requires experimental drug therapy.
  • A child's exacerbations of pain are only associated with medical procedures (such as radiation therapy, wound dressing, and bone marrow aspiration).
  • The child is receiving any other treatment that, in the opinion of the investigator, could interfere with the pain response.
  • For a female patient of childbearing potential: is pregnant or lactating. (Any female patient becoming pregnant during the study will be withdrawn from the study.)
  • The child has, in the opinion of the investigator, developmental delay that would interfere with the use of ACTIQ therapy.

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States30 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Scottish Rite Children's Medical Center

    Atlanta, Georgia, 30342

  • Children's Memorial Center

    Chicago, Illinois, 60614

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

  • Duke University Hospital

    Durham, North Carolina, 27710

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Childrens Medical Center

    Hartford, Connecticut, 06106

  • Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Kapi'olani Medical Center

    Honolulu, Hawaii, 96826

  • University Hospitals of Iowa

    Iowa City, Iowa, 52242

  • Nemours Childrens Clinic

    Jacksonville, Florida, 32207

  • Children's Hospital of Arkansas

    Little Rock, Arkansas, 72202

  • UCLA Pediatric Pain Program

    Los Angeles, California, 90095

  • Childrens Hospital of Wisconsin

    Milwaukee, Wisconsin, 53201

  • West Virginia University

    Morgantown, West Virginia, 99204

  • Vanderbilt University Medical

    Nashville, Tennessee, 37232

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Childrens Hospital of Orange

    Orange, California, 92868

  • Lucille Packard Childrens Hospital

    Palo Alto, California, 94304

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Children's Cancer and Blood Disorders Center

    San Antonio, Texas, 78207

  • Methodist Hospital

    San Antonio, Texas, 78229

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33607

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Tod Children's Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Puerto Rico1 site

  • San Jorge Childrens Medical

    San Juan, 00912

Other trials in Puerto Rico

About this study

Official title: A Double-Blind, Placebo-Comparison Study to Evaluate the Efficacy and Safety of ACTIQ® (Oral Transmucosal Fentanyl Citrate [OTFC®]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain

The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with cancer and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.

Read the detailed description

The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.

The secondary objectives are:

  • to evaluate the characteristics of BTP in children with pain, including their response to treatment
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children with regard to time to adequate analgesia by utilizing a stop watch to measure the time for each unit of study drug in the double blind phase
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the occurrence of inadequate analgesia as assessed by the use of rescue medication
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the numbers of patients who withdraw from the study because of inadequate analgesia
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the duration of analgesic effect by using the FPS-R administered at approximately 30, 45, and 60 minutes after the start of each unit of study drug after an optimal dosage is obtained
  • to determine the distribution of optimal doses of ACTIQ treatment for these children by age group (3 to under 6 years, 6 to under 11 years, and 11 to under 16 years)
  • to establish a safe and effective titration scheme for ACTIQ in these children during the open label phase
  • to evaluate the safety of ACTIQ treatment for these children through the assessment of adverse events, clinical laboratory assessments (serum chemistry and hematology), vital sign measurements (including blood pressure, heart rate, and respiration rate), hemoglobin-oxygen saturation level (SpO2, measured via pulse oximetry), electrocardiograms (ECGs), physical examinations, and level of sedation (measured by the University of Michigan Sedation Scale [UMSS])
  • to characterize the pharmacokinetics profile of ACTIQ (fentanyl citrate) in these children
  • to investigate the exposure and efficacy relationship between plasma concentration of fentanyl and clinical measures of analgesia
Being tested
ACTIQ®
Keywords
Breakthrough Pain, Cancer, Sickle Cell, Severe Burns, Children, Adolescents, Analgesia, Sickle Cell Disease, Non-Cancer
Medical subject headings
Neoplasms, Breakthrough Pain, Burns, Agnosia, Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTIQ®Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity differences as measured by the FPS-R

Secondary outcomes (5)

  1. Time to adequate analgesia

  2. Duration of analgesia

  3. Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs

  4. Amount of rescue medication

  5. Distribution of optimal doses

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2005 (estimated)
  2. Study startApr 2004
  3. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
38 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00236041
Sponsor's protocol ID
C8278b/202/BP/US-CA
Status last verified
May 2014
First submitted
7 Oct 2005
Last updated
9 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACTIQ® in people with Cancer and Breakthrough Pain, run by Cephalon at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity differences as measured by the FPS-R. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00236041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.

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