Opioid Induced ConstipationPhase 2NCT01459926
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
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 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 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
- History of constipation with onset after initiation of opioid therapy
- Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period
- Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the Screening Visit
- Willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation, treatment, and follow-up periods
Who cannot join
- Have participated in a clinical trial of an investigational drug or medical device within 30 days prior to Screening
- Have any condition that may affect drug absorption, (e.g., previous GI surgery)
- Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy 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, Opioid therapy
- 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
once daily
TD-1211Drug
Once daily
TD-1211Drug
Once daily
PlaceboDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: TD-1211 |
| Dose 2 | Experimental | Not described Receives: Drug: TD-1211 |
| Dose 3 | Experimental | Not described Receives: Drug: TD-1211 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
Measured: Between weeks 2 and 5
Secondary outcomes (1)
Change from baseline in the weekly SBM frequency in the last week of treatment
Measured: baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 217 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
- NCT01459926
- Sponsor's protocol ID
- 0084
- Status last verified
- May 2026
- First submitted
- 24 Oct 2011
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
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 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT01459926
- Acronym / sponsor ID
- 0084
- Conditions
- Opioid Induced Constipation
- Keywords
- Opioid induced constipation, OIC, Constipation, Opioid side effects, Morphine induced constipation, Opioid therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Glycyx TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Oct 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 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: TD-1211 |
| Dose 2 | Experimental | Drug: TD-1211 |
| Dose 3 | Experimental | Drug: TD-1211 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of constipation with onset after initiation of opioid therapy
- Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period
- Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the Screening Visit
- Willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation, treatment, and follow-up periods
Key exclusion criteria (3 listed)
- Have participated in a clinical trial of an investigational drug or medical device within 30 days prior to Screening
- Have any condition that may affect drug absorption, (e.g., previous GI surgery)
- Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol
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-1211once daily | Drug | Dose 1 |
| TD-1211Once daily | Drug | Dose 2 |
| TD-1211Once daily | Drug | Dose 3 |
| PlaceboOnce daily | Drug | Placebo |
Primary outcome
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
Time frame: Between weeks 2 and 5
1 secondary outcome
Change from baseline in the weekly SBM frequency in the last week of treatment
Time frame: baseline and 5 weeks
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.
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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 4 inclusion and 3 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?
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment (time frame: Between weeks 2 and 5). 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.