CompletedPhase 2

A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

United States95 participantsStarted 2011-10

Plain-language summary

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of TD-1211

Timeframe: 14 days

Trial details

NCT IDNCT01401985

SponsorGlycyx Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Opioid Induced Constipation trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.