- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00488969
Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Neuropathic pain occurs as a result of damage to neural tissue either in the peripheral or in the central nervous system. Three types of neuropathic pain after SCI are especially difficult to treat: at level central pain (ALCP), at level radicular pain (ALRP), and below level central pain (BLCP). Various analgesic medications with distinct mechanisms and sites of action are currently used in clinical practice for treatment of neuropathic pain after SCI, including antidepressants, anticonvulsants, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. These analgesic medications, when evaluated in animal models of SCI pain and in the treatment of other neuropathic pain states, have been shown to have only modest pain reducing effect. This modest effect is seen clinically as the majority of persons with SCI receiving these drugs continue to experience pain, which is severe and disabling in one third of cases.
This study proposes to examine the efficacy of oral modified release morphine in reducing pain in persons with neuropathic pain after SCI who have not adequately responded to other oral pharmacologic, psychologic, or physical interventions. Only subjects who have failed prior pain treatment regimes will be enrolled. Failure of pain regimen is defined as the presence of pain in spite of medication(s) or other pain treatment, such as biofeedback or other psychological or physical therapy interventions prescribed by a physician.
The following hypothesis will be tested: morphine, when added to non-opioid medications, is more effective than placebo in reducing pain and increasing activity and subjective well-being, in persons with ALCP, ALRP and BLCP. In order to test this hypothesis, a randomized, double blind, placebo-controlled, two period cross-over trial is proposed, during which subjects with ALCP, ALRP, and BLCP will receive daily placebo or modified release morphine while being closely monitored and assessed for: (1) adverse effects, (2) quality and intensity of pain, (3) intensity of allodynia and hyperalgesia, and (4) activity levels and well-being.
All subjects whether assigned to the placebo or active drug will be able to continue any previously prescribed or non-prescribed (over-the-counter) non-opioid medication that has been taken on a regular basis, without dose change, for at least three weeks prior to study entry. These medications may include but are not limited to the analgesics: acetaminophen and any non-steroidal anti-inflammatory drugs; local anesthetics- topical patches such as the lidocaine patch or otherwise; and adjuvant pain medications of the anti-depressant or anticonvulsant classes. Subjects will not be allowed to take any opioid medication, including non-opioid-opioid combination analgesics, other than the study drug for the duration of the study.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10029
- Mount Sinai School of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 - 65
- Diagnosis of traumatic spinal cord injury
- Neuropathic pain (pain related to the nervous system) rated at least 4 on a 11-point numeric rating scale at the time of screening
- Pain classified as at level radicular pain (ALRP), at level central pain (ALCP) or below level central pain (BLCP).
- Pain that is present regularly for at least 3 months prior to enrollment, in spite of medication or other pain treatment. This pain can be paroxysmal in nature (attacks of pain).
- Ability to understand instructions and reliably provide pain assessments
- Willingness to stop current opioid medications, if any
- If a female with childbearing potential, using an approved method of birth control (intrauterine device (IUD), barrier protection, a contraceptive implantation system or injection (Norplant® or Depo-Provera®), oral contraceptive pills, or celibacy)
Exclusion Criteria:
- A known sensitivity to opioids
- A history of substance or alcohol abuse within the past 2 years
- A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period
- Other chronic pain that cannot be differentiated from ALCP, ALRP, or BLCP
- A history of active cancer, excluding basal carcinoma of the skin, in the past 3 years
- Serum creatinine levels >= 2.5 mg/dl or hepatic (liver) dysfunction with serum ALT, AST, GGT, or total bilirubin >= 3 times the upper limit of normal
- Participation in any drug study in the last three months
- Currently pregnant or breastfeeding
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Modified-release morphine then Placebo
up to a ceiling dose of 120 mg
|
During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first.
During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication.
During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug.
Autres noms:
|
Comparateur placebo: Placebo then modified-release morphine
Matching placebo
|
During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first.
During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication.
During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pain severity
Délai: Average of daily ratings over 14 days
|
Pain severity rated using a 0-10 Numeric Rating Scale (NRS)
|
Average of daily ratings over 14 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Short McGill Pain Questionnaire (modified) (SF-McGill)
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Opioids cognitive effects scale
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Patient Generated Index for activity (PGI)
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Daily number of attacks of paroxysmal pain
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Quantitative sensory testing
Délai: up to 14 weeks
|
Allodynia, hyperalgesia, and temporal summation (determined using quantitative sensory testing)
|
up to 14 weeks
|
Subject global impression of change
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Short-Form 36 (SF-36)
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Positive And Negative Affect Schedule (PANAS)
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Brief Patient Health Questionnaire (PHQ-9)
Délai: up to 14 weeks
|
up to 14 weeks
|
|
Multidimensional Pain Inventory Life Interference subscale (MPI-LIS)
Délai: up to 14 weeks
|
up to 14 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux central
- Maladies du système nerveux
- La douleur
- Manifestations neurologiques
- Maladies neuromusculaires
- Maladies du système nerveux périphérique
- Traumatisme, système nerveux
- Maladies de la moelle épinière
- Névralgie
- Blessures et Blessures
- Blessures à la moelle épinière
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Analgésiques, Opioïdes
- Stupéfiants
- Morphine
Autres numéros d'identification d'étude
- H133N060027
- GCO # 90-135
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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