- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01393223
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
A Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Royal Oak, Michigan, États-Unis
- William Beaumont Hospitals
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:
- Male or female at least 18 years of age
IC/BPS diagnosed by a health care provider based the following criteria:
Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of ≥ 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain
Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications:
Antidepressants Antihistamines Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Analgesics Pentosan polysulfate
- Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period
- Provide signed informed consent
- Subject agrees to be available for the follow-up evaluations as required by the protocol
Exclusion Criteria:
Patients are excluded from enrollment in the study if any of the following are true:
- Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
- Have received investigational products or devices within 30 days prior to screening visit
- Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
- Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:
Antidepressants Antihistamines (use of antihistamines as needed for allergies is allowed) Anticonvulsants Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Pentosan polysulfate sodium Oral chondroitin
- Have indicated use of > 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period
- Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening.
- Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days
- Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days
- Evidence of renal impairment (creatinine > two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
- Post-void residual (PVR) urine volume of > 150 mL at screening
- Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results
- Previously received intravesical liposomes
- Urinary tract or prostatic infection in the past 90 days before study entry
- Active genital herpes or vaginitis
- Urethral diverticulum
- Pelvic malignancy within the past five years
- History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation
- History of bladder or prostate tumors (benign or malignant)
- Uncontrolled diabetes
- Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: LP-08 80mg
4 weekly intravesical administration of LP-08 80mg
|
Intravesical instillation of 80mg LP08
|
Comparateur actif: LP-08 20mg
4 weekly intravesical administration of LP-08 20mg
|
Intravesical instillation of 20mg LP08
|
Comparateur placebo: Normal Saline
Four weekly normal saline intravesical administration
|
Intravesical instillation of normal saline
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety of Intravesical LP08: number/severity of adverse events
Délai: Up to 31 weeks following treatment
|
The number/severity of adverse events throughout the study
|
Up to 31 weeks following treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy Voids Per Day (VPD)
Délai: 2, 4, 8, 16, 24 weeks following treatment
|
The change in voids per day (urinary frequency) as measured on a 3 day voiding diary
|
2, 4, 8, 16, 24 weeks following treatment
|
Efficacy Global Response Assessment (GRA)
Délai: 4, 8, 16, 24 weeks following treatment
|
Reporting a "moderate" or "marked" improvement on the GRA
|
4, 8, 16, 24 weeks following treatment
|
Efficacy Symptom
Délai: 2, 4, 8, 16, 24 weeks following treatment
|
The change in the symptoms and problems of interstitial cystitis from the baseline as measured by the O'Leary-Sant Interstitial Cystitis Symptom Index
|
2, 4, 8, 16, 24 weeks following treatment
|
Efficacy Visual Analog Scale (VAS)
Délai: 2, 4, 8, 16, 24 weeks following treatment
|
The change in pain as recorded on the VAS
|
2, 4, 8, 16, 24 weeks following treatment
|
Efficacy Diary
Délai: 2, 4, 8, 16, 24 weeks following treatment
|
The change from baseline in average voided volume, urgency and nocturia episodes per day as measured on a 3 day voiding diary
|
2, 4, 8, 16, 24 weeks following treatment
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PhaseII LP-08 IC/BPS
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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