ConstipationPhase 2OICNCT01983306
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
A Phase 2 study testing SP-333 1 mg, SP-333 3 mg and SP-333 6 mg in people with Constipation, run by Bausch Health Americas, Inc. at 42 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- SP-333 1 mg, SP-333 3 mg and SP-333 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 42 sitesUnited States
- Study dates
- Nov 2013to Apr 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening
- Must have active OIC at screening
- Active OIC must be confirmed during baseline screening bowel habit and symptom diary
- Must be on stable diet
Who cannot join
- Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)
- Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
- Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
- Unstable thyroid disease
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Synergy Research Site
Arlington, Texas, 76012
Synergy Research Site
Artesia, California, 90701
Synergy Research Site
Atlanta, Georgia, 30312
Synergy Research Site
Bloomington, Illinois, 61701
Synergy Research Site
Chattanooga, Tennessee, 37421
Synergy Research Site
Concord, North Carolina, 28025
Synergy Research Site
Dallas, Texas, 75218
Synergy Research Site
Dallas, Texas, 75231
Synergy Research Site
Dayton, Ohio, 45424
Synergy Research Site
Great Neck, New York, 11023
Synergy Research Site
Greensboro, North Carolina, 27403
Synergy Research Site
Hialeah, Florida, 33012
Synergy Research Site
Houston, Texas, 77081
Synergy Research Site
Huntsville, Alabama, 35801
Synergy Research Site
Laguna Hills, California, 92653
Synergy Research Site
Las Vegas, Nevada, 89102
Synergy Research Site
Medford, Oregon, 97504
Synergy Research Site
Miami, Florida, 33173
Synergy Research Site
Miami Beach, Florida, 33140
Synergy Research Site
Mobile, Alabama, 36608
Synergy Research Site
New York, New York, 10016
Synergy Research Site
Oceanside, California, 92056
Synergy Research Site
Oklahoma City, Oklahoma, 73101
Synergy Research Site
Oklahoma City, Oklahoma, 73104
Synergy Research Site
Oklahoma City, Oklahoma, 73119
Synergy Research Site
Orangeburg, South Carolina, 29118
Synergy Research Site
Phoenix, Arizona, 85018
Synergy Research Site
Plant City, Florida, 33563
Synergy Research Site
Plantation, Florida, 33317
Synergy Research Site
Port Orange, Florida, 32129
Synergy Research Site
Sacramento, California, 95831
Synergy Research Site
Salisbury, North Carolina, 28144
Synergy Research Site
San Antonio, Texas, 78209
Synergy Research Site
San Diego, California, 92103
Synergy Research Site
San Diego, California, 92108
Synergy Research Site
San Francisco, California, 94103
Synergy Research Site
Sarasota, Florida, 34239
Synergy Research Site
St Louis, Missouri, 63117
Synergy Research Site
Traverse City, Michigan, 49684
Synergy Research Site
West Palm Beach, Florida, 33409
Synergy Research Site
Winston-Salem, North Carolina, 27103
Synergy Research Site
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
- Conditions
- Constipation
- Being tested
- SP-333 1 mg, SP-333 3 mg, SP-333 6 mg, Placebo
- Keywords
- Constipation, Opioid, GC C Agonist, Pain
- Medical subject headings
- Constipation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-333 1 mgDrug
Tablet
SP-333 3 mgDrug
Tablet
SP-333 6 mgDrug
Tablet
PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| SP-333 1 mg | Experimental | 1 mg SP-333 orally once daily for 4-week Treatment Period Receives: Drug: SP-333 1 mg |
| SP-333 3 mg | Experimental | 3 mg SP-333 orally once daily for 4-week Treatment Period Receives: Drug: SP-333 3 mg |
| SP-333 6 mg | Experimental | 6 mg SP-333 orally once daily for 4-week Treatment Period Receives: Drug: SP-333 6 mg |
| Placebo | Placebo comparator | Placebo orally once daily for 4-week Treatment Period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
Measured: 4 Weeks
Secondary outcomes (1)
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
Compare the safety and tolerability of SP-333 (1, 3 \& 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs.
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 posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renata Tenenbaum, Study director, Synergy Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983306
- Sponsor's protocol ID
- SP333201-01
- Acronym
- OIC
- Status last verified
- May 2021
- First submitted
- 29 Oct 2013
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy
- ClinicalTrials.gov ID
- NCT01983306
- Acronym / sponsor ID
- OIC / SP333201-01
- Conditions
- Constipation
- Keywords
- Constipation, Opioid, GC C Agonist, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Nov 2013 (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 a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SP-333 1 mg | Experimental | Drug: SP-333 1 mg1 mg SP-333 orally once daily for 4-week Treatment Period |
| SP-333 3 mg | Experimental | Drug: SP-333 3 mg3 mg SP-333 orally once daily for 4-week Treatment Period |
| SP-333 6 mg | Experimental | Drug: SP-333 6 mg6 mg SP-333 orally once daily for 4-week Treatment Period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally once daily for 4-week Treatment Period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening
- Must have active OIC at screening
- Active OIC must be confirmed during baseline screening bowel habit and symptom diary
- Must be on stable diet
Key exclusion criteria (4 listed)
- Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)
- Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
- Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
- Unstable thyroid disease
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 |
|---|---|---|
| SP-333 1 mgTablet | Drug | SP-333 1 mg |
| SP-333 3 mgTablet | Drug | SP-333 3 mg |
| SP-333 6 mgTablet | Drug | SP-333 6 mg |
| PlaceboTablet | Drug | Placebo |
Primary outcome
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
Time frame: 4 Weeks
Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
1 secondary outcome
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
Time frame: 4 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 7 May 2021.
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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.
Renata Tenenbaum study director
Synergy Pharmaceuticals Inc.
42 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 SP-333 1 mg, SP-333 3 mg and SP-333 6 mg in people with Constipation, run by Bausch Health Americas, Inc. at 42 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 4 inclusion and 4 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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 number of spontaneous bowel movements during Week 4 of the 4-week treatment period (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 7 May 2021.