Opioid-induced ConstipationPhase 2NCT01382797
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
A Phase 2 study testing ALKS 37 in people with Opioid-induced Constipation, run by Alkermes, Inc. at 20 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-induced Constipation
- 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
- 157 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2011to Apr 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, 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
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Alkermes Study Site
Belvidere, New Jersey, 07823
Alkermes Study Site
Boise, Idaho, 83704
Alkermes Study Site
Brooklyn, New York, 11218
Alkermes Study Site
Cincinnati, Ohio, 45224
Alkermes Investigational Site
DeLand, Florida, 32724
Alkermes Study Site
Denver, Colorado, 80211
Alkermes Study Site
Kalamazoo, Michigan, 49009
Alkermes Study Site
Las Vegas, Nevada, 89144
Alkermes Study Site
Medford, Oregon, 97504
Alkermes Study Site
Mesa, Arizona, 85206
Alkermes Study Site
National City, California, 91950
Alkermes Study Site
New Orleans, Louisiana, 70114
Alkermes Study Site
Oceanside, California, 92056
Alkermes Study Site
Oklahoma City, Oklahoma, 73134
Alkermes Study Site
Ormond Beach, Florida, 32174
Alkermes Study Site
Pasadena, California, 91105
Alkermes Study Site
Phoenix, Arizona, 85053
Alkermes Study Site
San Antonio, Texas, 78228
Alkermes Study Site
St. Petersburg, Florida, 33709
Alkermes Study Site
Stockbridge, Georgia, 30281
About this study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).
- Conditions
- Opioid-induced Constipation
- Being tested
- ALKS 37, Placebo
- 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.
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.
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 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
- NCT01382797
- Sponsor's protocol ID
- ALK37-005
- Status last verified
- Jun 2012
- First submitted
- 24 Jun 2011
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
- ClinicalTrials.gov ID
- NCT01382797
- Acronym / sponsor ID
- ALK37-005
- Conditions
- Opioid-induced Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Jun 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, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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, 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
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
Time frame: 4 weeks
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
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 13 Jun 2012.
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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.
20 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 Opioid-induced Constipation, run by Alkermes, Inc. at 20 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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response. (time frame: 4 weeks). 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 13 Jun 2012.