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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01382797 |
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Date of registration:
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24/06/2011 |
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Primary sponsor: |
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Public title:
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ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
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Scientific title:
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A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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157 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01382797 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard Leigh-Pemberton, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alkermes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Are at least 18 years of age at time of consent
- Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
- Are receiving prescribed opioid medication for the management of chronic, non-cancer
pain
- Meet the criteria of OIC
- Agree to use an acceptable method of contraception for the duration of the study
Exclusion Criteria:
- Pregnancy and/or currently breastfeeding
- Clinically significant medical condition or illness (other than the condition for
which the pain medication is being prescribed)
- Receiving treatment with opioid therapy for cancer-related pain, abdominal pain,
scleroderma, and/or for the management of drug addiction
- Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI
structural abnormality known to affect bowel transit, produce GI obstruction, or
contribute to bowel dysfunction
- Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days
before the first study visit following screening until the end of the study
- Participation in a clinical trial of a pharmacological agent within 30 days before
screening
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Opioid-induced Constipation
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Intervention(s)
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Drug: ALKS 37
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Drug: Placebo
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Primary Outcome(s)
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Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
[Time Frame: 4 weeks]
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Secondary ID(s)
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ALK37-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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