Opioid Induced ConstipationPhase 2NCT01401985
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
A Phase 2 study testing TD-1211 in people with Opioid Induced Constipation, run by Glycyx Therapeutics at 1 site in United States.
Trial summary
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Induced Constipation
- What is being tested?
- TD-1211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable dose of opioids for at least 12 weeks before screening visit
- less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
- willing to stop laxatives and other bowel treatments; rescue laxative allowed
Who cannot join
- Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
- Have participated in another clinical trial of an investigational drug 30 days prior to screening
- History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
- History of chronic constipation prior to opioid therapy
- Females who are pregnant or breast feeding
- Have any condition that may affect drug absorption (e.g. previous GI surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Theravance Biopharma Investigational Site
Pasadena, California, 91105
About this study
Official title: A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
- Conditions
- Opioid Induced Constipation
- Being tested
- TD-1211, Placebo
- Keywords
- Opioid induced constipation, OIC, Constipation, Opioid side effects, morphine induced constipation
- Medical subject headings
- Opioid-Induced Constipation, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1211Drug
Capsules
PlaceboDrug
Capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days Receives: Drug: TD-1211 |
| Cohort 2 | Experimental | 5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days Receives: Drug: TD-1211 |
| Cohort 3 | Experimental | 5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days Receives: Drug: TD-1211 |
| Cohort 4 | Experimental | 5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days Receives: Drug: TD-1211 |
| Cohort 5 | Experimental | 2 mg TD-1211 once daily for 14 days Receives: Drug: TD-1211; Drug: Placebo |
| Cohort 6 | Experimental | 2.5 mg TD-1211 every 6 hours for 14 days Receives: Drug: TD-1211; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TD-1211
Measured: 14 days
Secondary outcomes (1)
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
Change from baseline in the weekly SBM and CSBM frequency
Measured: Weekly assessments throughout Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Induced ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycyx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401985
- Sponsor's protocol ID
- TD-1211-0076
- Status last verified
- May 2026
- First submitted
- 19 Jul 2011
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT01401985
- Acronym / sponsor ID
- TD-1211-0076
- Conditions
- Opioid Induced Constipation
- Keywords
- Opioid induced constipation, OIC, Constipation, Opioid side effects, morphine induced constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Glycyx TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TD-12115 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days |
| Cohort 2 | Experimental | Drug: TD-12115 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days |
| Cohort 3 | Experimental | Drug: TD-12115 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days |
| Cohort 4 | Experimental | Drug: TD-12115 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days |
| Cohort 5 | Experimental | Drug: TD-1211, Drug: Placebo2 mg TD-1211 once daily for 14 days |
| Cohort 6 | Experimental | Drug: TD-1211, Drug: Placebo2.5 mg TD-1211 every 6 hours for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stable dose of opioids for at least 12 weeks before screening visit
- less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
- willing to stop laxatives and other bowel treatments; rescue laxative allowed
Key exclusion criteria (6 listed)
- Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
- Have participated in another clinical trial of an investigational drug 30 days prior to screening
- History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
- History of chronic constipation prior to opioid therapy
- Females who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-1211Capsules | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| PlaceboCapsules | Drug | Cohort 5, Cohort 6 |
Primary outcome
Safety and tolerability of TD-1211
Time frame: 14 days
1 secondary outcome
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
Time frame: Weekly assessments throughout Treatment Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TD-1211 in people with Opioid Induced Constipation, run by Glycyx Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TD-1211 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.