A service of the U.S. National Institutes of Health Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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1 A service of the U.S. National Institutes of Health w Available: Final Rule for FDAAA 81 and NIH Policy on Clinical Trial Reporting Trial record 1 of 1 for: FENHYDPAI414 Previous Study Return to List Next Study Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery This study has been terminated. (Stopped prematurely in 28 due to IONSYS withdrawal off the market globally) Sponsor: Janssen Cilag N.V./S.A. Information provided by (Responsible Party): Janssen Cilag N.V./S.A. ClinicalTrials.gov Identifier: NCT77938 First received: October 23, 28 Last updated: April 22, 214 Last verified: April 214 History of Changes Full Text View Tabular View Study Results Disclaimer How to Read a Study Record Results First Received: January 1, 213 Study Type: Study Design: Condition: Intervention: Interventional Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment Pain, Postoperative Drug: Participant Flow Hide Participant Flow Recruitment Details Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations text entered. Pre Assignment Details Significant events and approaches for the overall study following participant enrollment, but prior to group assignment text entered. Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non irritated skin on the chest or upper arm. Duration of study Participant Flow: Overall Study STARTED /9

2 COMPLETED NOT COMPLETED 13 Study Prematurely Terminated 13 Baseline Characteristics Hide Baseline Characteristics Population text entered. Baseline Measures Overall 13 Age <=18 years Between 18 and 65 years 6 >=65 years 7 Gender Female 6 Male 7 Outcome Measures Hide All Outcome Measures 1. Primary: Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 [ Time Frame: Hour 24 ] Measure Title Measure Primary Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. Time Frame Hour 24 Population 2/9

3 Fentanyl ITS Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 statistical analysis provided for Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour Primary: Number of Participants With Intravenous Administration During Treatment With at Hour 48 [ Time Frame: Hour 48 ] Primary Measure Title Number of Participants With Intravenous Administration During Treatment With at Hour 48 Measure Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. Time Frame Hour 48 Population Number of Participants With Intravenous Administration During Treatment With at Hour /9

4 statistical analysis provided for Number of Participants With Intravenous Administration During Treatment With at Hour Primary: Number of Participants With Intravenous Administration During Treatment With at End of Study Treatment [ Time Frame: End of Study treatment (Hour 72) ] Measure Title Measure Primary Number of Participants With Intravenous Administration During Treatment With at End of Study Treatment Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. Time Frame End of Study treatment (Hour 72) Population Number of Participants With Intravenous Administration During Treatment With at End of Study Treatment statistical analysis provided for Number of Participants With Intravenous Administration During Treatment With at End of Study Treatment 4. Secondary: Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ] Measure Title Measure Time Frame Secondary Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: Overall, would you rate this method of pain control as being poor, fair, good, or excellent? Hour 72 or early withdrawal Population 4/9

5 Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control statistical analysis provided for Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control 5. Secondary: Number of Participants With Nurse Global Assessment of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ] Measure Title Measure Time Frame Secondary Number of Participants With Nurse Global Assessment of Method of Pain Control The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" Hour 72 or early withdrawal Population Number of Participants With Nurse Global Assessment of Method of Pain Control statistical analysis provided for Number of Participants With Nurse Global Assessment of Method of Pain Control 5/9

6 6. Secondary: Number of Participants With Physician Global Assessment of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ] Measure Title Measure Time Frame Secondary Number of Participants With Physician Global Assessment of Method of Pain Control The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" Hour 72 or early withdrawal Population Number of Participants With Physician Global Assessment of Method of Pain Control statistical analysis provided for Number of Participants With Physician Global Assessment of Method of Pain Control Serious Adverse Events Hide Serious Adverse Events Time Frame From start of study treatment upto Day 14 Additional text entered. Serious Adverse Events 6/9

7 Total, serious adverse events Nervous system disorders Peroneal nerve palsy (severe) * 1 * Events were collected by non systematic assessment 1 Term from vocabulary, MedDRA version 12. Other Adverse Events Hide Other Adverse Events Time Frame From start of study treatment upto Day 14 Additional text entered. Frequency Threshold Threshold above which other adverse events are reported Other Adverse Events Total, other (not including serious) adverse events # participants affected / at risk 1/13 (76.92%) Gastrointestinal disorders Nausea * 1 # participants affected / at risk 2/13 (15.38%) Constipation * 1 General disorders Application site reaction * 1 # participants affected / at risk 2/13 (15.38%) Application site discolouration * 1 # events 2 Application site swelling * 1 Application site pruritus (left side) * 1 Application site pruritus (right side) * 1 Pyrexia * 1 Application site reaction (left side) * 1 7/9

8 Application site reaction (right side) * 1 Injury, poisoning and procedural complications Inadequate analgesia * 1 # participants affected / at risk 2/13 (15.38%) Nervous system disorders Headache * 1 Peroneal nerve palsy (moderate) * 1 Psychiatric disorders Euphoric mood * 1 Renal and urinary disorders Urinary retension * 1 # participants affected / at risk 3/13 (23.8%) Respiratory, thoracic and mediastinal disorders Dyspnoea * 1 Vascular disorders Hypotension * 1 * Events were collected by non systematic assessment 1 Term from vocabulary, MedDRA version 12. Limitations and Caveats Hide Limitations and Caveats Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data efficacy results were reported because the study was prematurely terminated, following the worldwide voluntary withdrawal of Fentanyl Iontophoretic Transdermal System (IONSYS) by Janssen Cilag. More Information Hide More Information Certain Agreements: Principal Investigators are NOT employed by the organization sponsoring the study. There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Results Point of Contact: Name/Title: Study Responsible Physician Organization: Janssen Cilag Belgium phone: /9

9 Responsible Party: Janssen Cilag N.V./S.A. ClinicalTrials.gov Identifier: NCT77938 History of Changes Other Study ID Numbers: CR15121 FENHYDPAI Study First Received: October 23, 28 Results First Received: January 1, 213 Last Updated: April 22, 214 Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products 9/9

10 Disclaimer Information in this posting shall not be considered to be a claim for any marketed product. Some information in this posting may differ from, or not be included in, the approved labeling for the product. Please refer to the full prescribing information for indications and proper use of the product.

Previous Study Return to List Next Study

A service of the U.S. National Institutes of Health Trial record 1 of 1 for: 42603ATT3013 Previous Study Return to List Next Study A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS