Opioid-induced ConstipationPhase 2NCT01100151
ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
A Phase 2 study testing RDC-1036 (ALKS 37) in people with Opioid-induced Constipation, run by Alkermes, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid-induced Constipation
- What is being tested?
- RDC-1036 (ALKS 37)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2010to Dec 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- Body mass index (BMI) of 19 to 35 kg/m2 at screening
- Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
- Diagnosis of opioid-induced constipation (OIC)
- Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during the study.
Who cannot join
- Pregnancy and/or currently breastfeeding
- Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
- Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
- Any gastrointestinal (GI) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
- Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
- Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
- Participation in a clinical trial of a pharmacological agent within 30 days before screening
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Alkermes Investigational Site
Anaheim, California, 92801
Alkermes Investigational Site
Boise, Idaho, 83704
Alkermes Investigational Site
Dayton, Ohio, 45432
Alkermes Investigational Site
DeLand, Florida, 32734
Alkermes Investigational Site
New Orleans, Louisiana, 70114
Alkermes Investigative Site
New Smyrna Beach, Florida, 32168
Alkermes Investigational Site
Pasadena, California, 91105
Alkermes Investigational Site
Salt Lake City, Utah, 84106
Alkermes Investigational Site
Sheffield, Alabama, 35660
Alkermes Investigational Site
Walnut Creek, California, 94598
Alkermes Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
Read the detailed description
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
- Conditions
- Opioid-induced Constipation
- Being tested
- RDC-1036 (ALKS 37), Placebo
- Keywords
- Opioid-induced constipation, RDC-1036, ALKS 37
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDC-1036 (ALKS 37)Drug
Capsules for oral administration
PlaceboDrug
Capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| RDC-1036 (ALKS 37) | Experimental | Capsules for oral administration Receives: Drug: RDC-1036 (ALKS 37) |
| Placebo | Placebo comparator | Capsules for oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Measured: 4 Weeks
Number of subjects reporting treatment-emergent adverse events (TEAEs)
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Measured: 6 Weeks
Secondary outcomes (3)
Change in rescue laxative use from pre-treatment to treatment period
Measured: 4 Weeks
Study drug dose prior to first SBM after randomization
Measured: 4 weeks
Scores to study-related questionnaires
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard L. Silverman, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100151
- Sponsor's protocol ID
- ALK37-003
- Status last verified
- Aug 2011
- First submitted
- 7 Apr 2010
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain
- ClinicalTrials.gov ID
- NCT01100151
- Acronym / sponsor ID
- ALK37-003
- Conditions
- Opioid-induced Constipation
- Keywords
- Opioid-induced constipation, RDC-1036, ALKS 37
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Apr 2010 (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.
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
Detailed description
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDC-1036 (ALKS 37) | Experimental | Drug: RDC-1036 (ALKS 37)Capsules for oral administration |
| Placebo | Placebo comparator | Drug: PlaceboCapsules for oral administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 70 years of age
- Body mass index (BMI) of 19 to 35 kg/m2 at screening
- Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
- Diagnosis of opioid-induced constipation (OIC)
- Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during the study.
Key exclusion criteria (7 listed)
- Pregnancy and/or currently breastfeeding
- Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
- Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
- Any gastrointestinal (GI) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
- Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
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 |
|---|---|---|
| RDC-1036 (ALKS 37)Capsules for oral administration | Drug | RDC-1036 (ALKS 37) |
| PlaceboCapsules for oral administration | Drug | Placebo |
Primary outcome
Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Time frame: 4 Weeks
Number of subjects reporting treatment-emergent adverse events (TEAEs)
Time frame: 6 Weeks
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
3 secondary outcomes
Change in rescue laxative use from pre-treatment to treatment period
Time frame: 4 Weeks
Study drug dose prior to first SBM after randomization
Time frame: 4 weeks
Scores to study-related questionnaires
Time frame: 6 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 23 Aug 2011.
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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.
Bernard L. Silverman, MD study director
Alkermes, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDC-1036 (ALKS 37) in people with Opioid-induced Constipation, run by Alkermes, Inc. at 11 sites 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 5 inclusion and 7 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 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. 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 in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period (time frame: 4 Weeks). The study lists 2 primary outcomes in all. 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 23 Aug 2011.