NCT01333540

Brief Summary

A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

March 30, 2011

Last Update Submit

January 19, 2021

Conditions

Opioid-induced Constipation (OIC)

Keywords

constipationopioid induced

Outcome Measures

Primary Outcomes (1)

  • Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211

    Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks

Secondary Outcomes (1)

  • Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels

    Continuous assessments for up to six weeks

Study Arms (2)

Active

EXPERIMENTAL

Escalating Doses of TD-1211

Drug: TD-1211

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TD-1211DRUG

Escalating doses

Active
PlaceboDRUG

Placebo once daily

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 18 and 65 years of age, inclusive
  • Subjects with documented OIC on stable opioid regimen
  • Willingness to stop all laxatives throughout run-in and treatment period

You may not qualify if:

  • Any clinically significant findings in subjects with OIC
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Opioid-Induced ConstipationConstipation

Interventions

3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 12, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

US(1)