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A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation

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ClinicalTrials.gov Identifier: NCT01040637
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).

Condition or disease Intervention/treatment Phase
Healthy Opioid-induced Constipation Drug: TD-1211 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation
Study Start Date : January 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TD-1211 dose level 1
Ascending doses
 Drug: TD-1211
Dose level 1
Experimental: TD-1211 dose level 2
Ascending doses
 Drug: TD-1211
Dose level 2
Experimental: TD-1211 dose level 3
Ascending doses
 Drug: TD-1211
Dose level 3
Experimental: TD-1211 dose level 4
Ascending doses
 Drug: TD-1211
Dose Level 4
Experimental: TD-1211 OIC dose level 1
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose level 2
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose leve 3
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose level 4
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose level 5
Ascending doses
 Drug: TD-1211
Ascending doses
Placebo Comparator: Placebo
Ascending doses
 Drug: Placebo
Ascending doses


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation [ Time Frame: Daily pre and post dose assessments throughout the duration of the study period ]

Secondary Outcome Measures :
  1. Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration [ Time Frame: Daily pre and post dose assessments throughout the duration of the study period ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females between 18 and 65 years of age, inclusive
  • Healthy subjects and subjects with documented OIC on stable opioid regimen
  • Willingness to stop all laxatives throughout the OIC screening and treatment period

Exclusion Criteria:

  • Any clinically significant finding in healthy subjects
  • Have participated in another clinical trial of an investigational drug 30 days prior to screening
  • History of chronic constipation prior to opioid therapy in OIC subjects
  • Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040637


Locations
United States, California
Clinical Research Unit
Pasadena, California, United States, 91105
United States, Texas
Clinical Research Unit
San Antonio, Texas, United States, 78209
United States, Utah
Clinical Research Unit
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT01040637     History of Changes
Other Study ID Numbers: 0067
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):
Healthy subjects

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms