OICPhase 2NCT01418092
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
A Phase 2 study testing ALKS 37 in people with OIC, run by Alkermes, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OIC
- What is being tested?
- ALKS 37
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age at time of consent
- Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
- Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
- Meet the criteria of OIC
- Agree to use an acceptable method of contraception for the duration of 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) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
- Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, 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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Alkermes Investigational Site
Anaheim, California, 92804
Alkermes Investigational Site
Austin, Texas, 78756
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Daytona Beach, Florida, 32117
Alkermes Investigational Site
Houston, Texas, 77098
Alkermes Investigational Site
Indianapolis, Indiana, 46250
Alkermes Investigational Site
Las Vegas, Nevada, 89119
Alkermes Investigational Site
Marietta, Georgia, 30060
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19139
Alkermes Investigational Site
Plantation, Florida, 33317
Alkermes Investigational Site
Raleigh, North Carolina, 27612
Alkermes Investigational Site
Willingboro, New Jersey, 08046
About this study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
- Conditions
- OIC
- Being tested
- ALKS 37, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 37Drug
Capsules for oral administration
PlaceboDrug
Capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules for oral administration Receives: Drug: Placebo |
| ALKS 37 | Experimental | Capsules for oral administration Receives: Drug: ALKS 37 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the weekly average of complete spontaneous bowel movements during treatment
Measured: Weeks 1 through 4 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJun 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 OICStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Leigh-Pemberton, M.D., Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418092
- Sponsor's protocol ID
- ALK37-007
- Status last verified
- Jul 2012
- First submitted
- 15 Aug 2011
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
- ClinicalTrials.gov ID
- NCT01418092
- Acronym / sponsor ID
- ALK37-007
- Conditions
- OIC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Aug 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.
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboCapsules for oral administration |
| ALKS 37 | Experimental | Drug: ALKS 37Capsules for oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are at least 18 years of age at time of consent
- Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
- Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
- Meet the criteria of OIC
- Agree to use an acceptable method of contraception for the duration of the study
Key exclusion criteria (6 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) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
- Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
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 |
|---|---|---|
| ALKS 37Capsules for oral administration | Drug | ALKS 37 |
| PlaceboCapsules for oral administration | Drug | Placebo |
Primary outcome
Change from baseline in the weekly average of complete spontaneous bowel movements during treatment
Time frame: Weeks 1 through 4 of treatment
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 7 Aug 2012.
Related trials for OIC
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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.
Richard Leigh-Pemberton, M.D. study director
Alkermes, Inc.
13 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 ALKS 37 in people with OIC, run by Alkermes, Inc. at 13 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 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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 from baseline in the weekly average of complete spontaneous bowel movements during treatment (time frame: Weeks 1 through 4 of treatment). 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 7 Aug 2012.