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A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain


Phase 4
18 Years
90 Years
Not Enrolling
Both
Opioid-Induced Constipation

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain


Inclusion Criteria:



- Is a man or woman aged 18 years or older.

- Has a body weight >= 38 kg.

- Has cancer (active or in remission), and has cancer-related pain (ie, pain due to
cancer or treatment of cancer).

- Has a life expectancy of >= 6 months.

- Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology
Group (ECOG) scale.

- Is taking opioids for cancer-related pain, and not just as-needed doses.

- Has a diagnosis of OIC as determined by the investigator.

- Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria:

- Has a history of chronic constipation before starting opioids.

- Has renal disease receiving dialysis.

- Has an ostomy for stools.

- Is a pregnant or breastfeeding woman.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.

Outcome Time Frame:

1 Day

Safety Issue:

Yes

Principal Investigator

Jeff Cohn

Investigator Role:

Study Director

Investigator Affiliation:

Salix Pharmaceuticals

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

3200K1-4006

NCT ID:

NCT00858754

Start Date:

March 2009

Completion Date:

August 2009

Related Keywords:

  • Opioid-Induced Constipation
  • opioid induced constipation
  • Cancer patients
  • methylnaltrexone
  • Constipation

Name

Location

Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Milwaukee, Wisconsin  53215