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New drug aims to ease Opioid-Related constipation

NCT ID NCT01401985

Symptom relief Sponsor: Glycyx Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a drug called TD-1211 in 95 people who had constipation from taking opioid pain medications. The main goal was to see if the drug was safe and tolerable. Researchers also looked at whether it increased the number of complete and spontaneous bowel movements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TD-1211
What this could lead to
If it works, this could lead to a new treatment option for constipation caused by opioid pain medications.
What could go wrong
This is an early pilot study with only 95 people, so results may not apply to everyone. The drug might not work better than a placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

95 people

The number who actually took part.

Start date

Oct 2011

Finished

Aug 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

constipation disorder opioid-induced constipation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid induced constipation

Contacts and locations

Locations

  • Theravance Biopharma Investigational Site

    Pasadena, California, 91105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.