Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, And Parallel-Group Study Of Subcutaneous Methylnaltrexone (MOA-728) For The Treatment Of Opioid-Induced Constipation In Adult Subjects
Panoramica dello studio
Descrizione dettagliata
Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.
Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.
All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 137-701
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Seoul, Corea, Repubblica di, 135-710
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Seoul, Corea, Repubblica di, 152-703
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Kyounggi-do
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Koyang-shi, Kyounggi-do, Corea, Repubblica di, 410-719
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Tainan, Taiwan, 70428
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Taipei TOC, Taiwan, 100
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy >= 1 month;
- Is receiving a regular dose of opioids for the control of pain;
- Has a diagnosis of opioid induced constipation;
- Is on a stable laxative regimen.
Exclusion Criteria:
- Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;
- Has evidence of current fecal impaction;
- Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;
- Has a body weight less than 27 kg
- Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Methylnaltrexone double-blind
Methylnaltrexone once every other day.
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Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
Altri nomi:
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Comparatore placebo: Placebo
Placebo once every other day.
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Subjects received matching placebo injections. Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments). |
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Altro: Methylnaltrexone open-label
Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.
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Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection.
Lasso di tempo: Up to 4 hours after the first injection
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There were 2 co-primary endpoints for this study.
This measurement is the first of the 2 co-primary endpoints.
This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups.
To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction).
Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only.
Therefore, no efficacy results are presented for the open-label period.
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Up to 4 hours after the first injection
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The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period.
Lasso di tempo: Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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This measurement is the second of the 2 co-primary endpoints.
This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups.
The definition of RFBM is described above (see first co-primary endpoint).
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Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration.
Lasso di tempo: Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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This endpoint measures the percentage of injections resulting in RFBMs within 4 hours after test article administration during the double-blind period.
The percentage of injections resulting in RFBMs is calculated for each patient and then data are expressed as the mean (± standard deviation) percentage for the MNTX and placebo groups.
The definition of RFBM is described above (see first co-primary endpoint).
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Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Enoch Bortey, Bausch Health Americas, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Disturbi Correlati a Sostanze
- Segni e sintomi, Digestivo
- Disturbi correlati agli stupefacenti
- Stipsi
- Costipazione indotta da oppioidi
- Effetti fisiologici delle droghe
- Agenti del sistema nervoso periferico
- Agenti del sistema sensoriale
- Antagonisti narcotici
- Metilnaltrexone
Altri numeri di identificazione dello studio
- 3200K1-3361
- B2541004
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