- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00293033
Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
A Double-blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
North Carolina
-
Wilmington, North Carolina, Vereinigte Staaten, 28412
- Ppd Development
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
- 18 years or older
- Patient must have pain associated with cancer or cancer treatment.
- Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg).
- Regularly experiences 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
- At least partial relief of breakthrough pain by use of opioid therapy
- Subject must be able to self-administer the study medication correctly.
- Subject must be willing and able to complete the electronic diary card with each pain episode.
- Signed consent must be obtained at screening prior to any procedures being performed.
Exclusion Criteria:
- Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
- Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
- Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
- Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
- Moderate (Grade 3) to severe (Grade 4) mucositis (Subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation.)
- Strontium 89 therapy within the previous 6 months
- Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
- Use of an investigational drug within 4 weeks preceding this study
- History of hypersensitivity or intolerance to fentanyl
- Regularly more than 4 episodes per day
- Eastern Cooperative Oncology Group (ECOG) performance status of 4 or 5
- Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: Placebo
|
BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form.
The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth.
The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened.
The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
Andere Namen:
|
Experimental: BEMA™ Fentanyl
BioErodible MucoAdhesive (BEMA) Fentanyl
|
BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form.
The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth.
The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened.
The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Summary of Pain Intensity Differences (SPID)
Zeitfenster: 0-30 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. |
0-30 minutes
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
SPID
Zeitfenster: 0-5 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-5 minutes
|
SPID
Zeitfenster: 0-10 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-10 minutes
|
SPID
Zeitfenster: 0-15 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-15 minutes
|
SPID
Zeitfenster: 0-45 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-45 minutes
|
SPID
Zeitfenster: 0-60 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-60 minutes
|
PID
Zeitfenster: 5 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
5 minutes after dosing
|
PID
Zeitfenster: 10 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
10 minutes after dosing
|
PID
Zeitfenster: 15 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
15 minutes after dosing
|
PID
Zeitfenster: 30 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
30 minutes after dosing
|
PID
Zeitfenster: 45 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
45 minutes after dosing
|
PID
Zeitfenster: 60 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
60 minutes after dosing
|
Pain Relief
Zeitfenster: 5 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
5 minutes after dosing
|
Pain Relief
Zeitfenster: 10 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
10 minutes after dosing
|
Pain Relief
Zeitfenster: 15 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
15 minutes after dosing
|
Pain Relief
Zeitfenster: 30 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
30 minutes after dosing
|
Pain Relief
Zeitfenster: 45 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
45 minutes after dosing
|
Pain Relief
Zeitfenster: 60 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
60 minutes after dosing
|
Total Pain Relief
Zeitfenster: 5 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
5 minutes
|
Total Pain Relief
Zeitfenster: 10 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
10 minutes
|
Total Pain Relief
Zeitfenster: 15 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
15 minutes
|
Total Pain Relief
Zeitfenster: 30 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
30 minutes
|
Total Pain Relief
Zeitfenster: 45 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
45 minutes
|
Total Pain Relief
Zeitfenster: 60 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
60 minutes
|
Subject Overall Satisfaction With Study Drug
Zeitfenster: 60 minutes or at time of rescue medication use
|
Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent).
|
60 minutes or at time of rescue medication use
|
Percentage of Pain Free Episodes
Zeitfenster: 5 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
5 minutes
|
Percentage of Pain Free Episodes
Zeitfenster: 10 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
10 minutes
|
Percentage of Pain Free Episodes
Zeitfenster: 15 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
15 minutes
|
Percentage of Pain Free Episodes
Zeitfenster: 30 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
30 minutes
|
Percentage of Pain Free Episodes
Zeitfenster: 45 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
45 minutes
|
Percentage of Pain Free Episodes
Zeitfenster: 60 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
60 minutes
|
Episodes With at Least 50% Decreases in Pain
Zeitfenster: 15 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
15 minutes
|
Episodes With at Least 50% Decreases in Pain
Zeitfenster: 30 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
30 minutes
|
Episodes With at Least 50% Decreases in Pain
Zeitfenster: 45 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
45 minutes
|
Episodes With at Least 50% Decreases in Pain
Zeitfenster: 60 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
60 minutes
|
Episodes With at Least 33% Decreases in Pain
Zeitfenster: 15 minutes
|
Number of episodes where the total pain score has at least a 33% reduction from baseline.
|
15 minutes
|
Episodes With at Least 33% Decreases in Pain
Zeitfenster: 30 minutes
|
Number of episodes where the total pain score has at least a 33% reduction from baseline.
|
30 minutes
|
Episodes With at Least 33% Decreases in Pain
Zeitfenster: 45 minutes
|
Number of episodes where the total pain score has at least a 33% reduction from baseline.
|
45 minutes
|
Episodes With at Least 33% Decreases in Pain
Zeitfenster: 60 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
60 minutes
|
Episodes With Complete Pain Relief
Zeitfenster: 5 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
5 minutes
|
Episodes With Complete Pain Relief
Zeitfenster: 10 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
10 minutes
|
Episodes With Complete Pain Relief
Zeitfenster: 15 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
15 minutes
|
Episodes With Complete Pain Relief
Zeitfenster: 30 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
30 minutes
|
Episodes With Complete Pain Relief
Zeitfenster: 45 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
45 minutes
|
Episodes With Complete Pain Relief
Zeitfenster: 60 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
60 minutes
|
Rescue Medication Usage
Zeitfenster: 28 Days
|
Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug.
Percentage of episodes when rescue medication was used per subject is analyzed.
|
28 Days
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
SPID in Neuropathic Pain Subpopulation
Zeitfenster: 15 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
15 minutes
|
SPID in Neuropathic Pain Subpopulation
Zeitfenster: 30 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
30 minutes
|
SPID in Neuropathic Pain Subpopulation
Zeitfenster: 45 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
45 minutes
|
SPID in Neuropathic Pain Subpopulation
Zeitfenster: 60 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
60 minutes
|
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Andrew Finn, PharmD, BioDelivery Sciences International
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Durchbruchschmerzen
- Physiologische Wirkungen von Arzneimitteln
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Anästhetika, intravenös
- Anästhesie, Allgemein
- Anästhetika
- Analgetika, Opioide
- Betäubungsmittel
- Adjuvantien, Anästhesie
- Fentanyl
Andere Studien-ID-Nummern
- FEN-201
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Schmerzen
-
Foundation IRCCS San Matteo HospitalAktiv, nicht rekrutierendGreater Trochanteric Pain Syndrome beider unteren ExtremitätenItalien
-
Gazi UniversityAbgeschlossenGesäß-Tendinitis | Greater Trochanteric Pain Syndrome beider unteren ExtremitätenTruthahn
-
Lawson Health Research InstituteNoch keine RekrutierungSchmerzen im unteren Rücken | Greater Trochanteric Pain Syndrome
-
C.R.Darnall Army Medical CenterUnbekanntGreater Trochanteric Pain SyndromeVereinigte Staaten
-
Guna S.p.aBeendetGreater Trochanteric Pain Syndrome | Pertrochantäre Fraktur | Gesäß-Tendinitis | GTPS - Greater Trochanteric Pain Syndrome | Sehnenerkrankung | GesäßmuskulaturItalien
-
Smith & Nephew, Inc.AbgeschlossenHüftschmerzen chronisch | Greater Trochanteric Pain SyndromeAustralien
-
NHS Greater Glasgow and ClydeNHS Research ScotlandRekrutierungGreater Trochanteric Pain SyndromeVereinigtes Königreich
-
Kutahya Health Sciences UniversityRekrutierungGreater Trochanteric Pain SyndromeTruthahn
-
Massachusetts General HospitalAbgeschlossenGreater Trochanteric Pain SyndromeVereinigte Staaten
-
Montefiore Medical CenterNoch keine RekrutierungGreater Trochanteric Pain SyndromeVereinigte Staaten
Klinische Studien zur Placebo
-
SamA Pharmaceutical Co., LtdUnbekanntAkute Bronchitis | Akute Infektion der oberen AtemwegeKorea, Republik von
-
National Institute on Drug Abuse (NIDA)AbgeschlossenCannabiskonsumVereinigte Staaten
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAbgeschlossenMännliche Probanden mit Typ-II-Diabetes (T2DM)Deutschland
-
Instituto de Investigación Hospital Universitario...Creaciones Aromáticas Industriales, S.A. (CARINSA)Abgeschlossen
-
Texas A&M UniversityNutraboltAbgeschlossenGlucose and Insulin Response
-
Soroka University Medical CenterAbgeschlossen
-
Regado Biosciences, Inc.AbgeschlossenGesunder FreiwilligerVereinigte Staaten
-
Longeveron Inc.BeendetHypoplastisches LinksherzsyndromVereinigte Staaten
-
ItalfarmacoAbgeschlossenBecker-MuskeldystrophieNiederlande, Italien