Chronic Idiopathic ConstipationPhase 2CICNCT01053962
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
A Phase 2 study testing SP-304 0.3 mg, SP-304 1.0 mg and SP-304 3.0 mg in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 14 sites in United States.
Trial summary
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- SP-304 0.3 mg, SP-304 1.0 mg and SP-304 3.0 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2010to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
- Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
- Subject has a body mass index (BMI) between 18 and 35 kg/m2.
- Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.
Who cannot join
- Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
- Subjects who meet the Rome III criteria for IBS.
- Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Advanced Clinical Research
Anaheim, California, 92801
Universtiy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
A.G.A. Clinical Trials
Hialeah, Florida, 33012
DCOL Center for Clinical Research
Longview, Texas, 75605
Novara Clinical Research
Mesa, Arizona, 85206
Miami Ressearch and Associates
Miami, Florida, 33143
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Advanced Clinical Research
Orange, California, 92869
Wake Research Associates
Raleigh, North Carolina, 27612
Lee Research Institute
Shawnee Mission, Kansas, 66218
Pioneer Research Solutions
Sugar Land, Texas, 77479
Genova Clinical Research
Tucson, Arizona, 85741
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.
Read the detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment. Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected that each patient will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- SP-304 0.3 mg, SP-304 1.0 mg, SP-304 3.0 mg, SP-304 9.0 mg, Placebo
- Keywords
- Chronic Idiopathic Constipation, Constipation, Irritable Bowel Syndrome
- Medical subject headings
- Constipation, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-304 0.3 mgDrug
SP-304 0.3 mg
SP-304 1.0 mgDrug
SP-304 1.0 mg
SP-304 3.0 mgDrug
SP-304 3.0 mg
SP-304 9.0 mgDrug
SP-304 9.0 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SP-304 0.3 mg | Experimental | SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days. Receives: Drug: SP-304 0.3 mg |
| SP-304 1.0 mg | Experimental | SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days. Receives: Drug: SP-304 1.0 mg |
| SP-304 3.0 mg | Experimental | SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days Receives: Drug: SP-304 3.0 mg |
| SP-304 9.0 mg | Experimental | SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days. Receives: Drug: SP-304 9.0 mg |
| Placebo | Placebo comparator | Placebo tablet by mouth once daily for 14 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Incidences of adverse events from Baseline through the end of the Follow-up period.
Measured: 21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)
Secondary outcomes (4)
Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
Using a Daily Diary, patients recorded the number of spontaneous bowel movements having the sensation of complete evacuation (Complete Spontaneous Bowel Movement - CSBM). The total number of spontaneous bowel movements associated with a feeling of complete evacuation were summed and divided by 2 (the number of weeks in treatment). Change was calculated as the difference between the number of the CSBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.
Measured: Study days 1 through 14
Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
Using a Daily Diary, patients recorded the number of spontaneous bowel movements (SBM). The overall weekly frequency was calculated as the total number of SBMs divided by 2 (the number weeks of treatment). Change was calculated as the difference between the number of the SBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.
Measured: Study Days 1 through 14
Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
Using a Daily Diary, patients recorded Stool Consistency using the 7-point Bristol Stool Form Scale (BSFS) (1 = separate hard lumps, like nuts; 2 sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces, entirely liquid). Changes in mean BSFS were assessed from the average 14-day pretreatment baseline to the average during the 2-week treatment period.
Measured: Study day 1 through 14
Changes From Baseline Overall in Ease of Passage (Straining)
Using a Daily Diary, patients recorded Ease of Passage (Straining) using the 7-point Ease-of-Passage Scale (1 = manual disimpaction/enema needed, 2 = severe straining, 3 = moderate straining, 4 = mild straining, 5 = no straining, 6 = urgency, 7 = incontinent). Changes in overall ease of passage (Straining) were assessed from the average 14-day pretreatment baseline to average during the 2-week treatment period
Measured: Study Days 1 through 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary S Jacob, Ph.D., Study director, Synergy Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053962
- Sponsor's protocol ID
- SP-SP304201-09
- Acronym
- CIC
- Status last verified
- Dec 2019
- First submitted
- 12 Jan 2010
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shailubhai K, Talluto C, Comiskey S, Foss J, Joslyn A, Jacob G. Phase II Clinical Evaluation of SP-304, a Guanylate Cyclase-C Agonist, for Treatment of Chronic Constipation. Am J Gastroenterology 105 (Supp 1): S487, 2010
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT01053962
- Acronym / sponsor ID
- CIC / SP-SP304201-09
- Conditions
- Chronic Idiopathic Constipation
- Keywords
- Chronic Idiopathic Constipation, Constipation, Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.
Detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment. Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected that each patient will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SP-304 0.3 mg | Experimental | Drug: SP-304 0.3 mgSP-304 0.3 mg tablet by mouth once daily for 14 consecutive days. |
| SP-304 1.0 mg | Experimental | Drug: SP-304 1.0 mgSP-304 1.0 mg tablet by mouth once daily for 14 consecutive days. |
| SP-304 3.0 mg | Experimental | Drug: SP-304 3.0 mgSP-304 3.0 mg tablet by mouth once daily for 14 consecutive days |
| SP-304 9.0 mg | Experimental | Drug: SP-304 9.0 mgSP-304 9.0 mg tablet by mouth once daily for 14 consecutive days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet by mouth once daily for 14 consecutive days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
- Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
- Subject has a body mass index (BMI) between 18 and 35 kg/m2.
- Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.
Key exclusion criteria (3 listed)
- Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
- Subjects who meet the Rome III criteria for IBS.
- Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
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-304 0.3 mgSP-304 0.3 mg | Drug | SP-304 0.3 mg |
| SP-304 1.0 mgSP-304 1.0 mg | Drug | SP-304 1.0 mg |
| SP-304 3.0 mgSP-304 3.0 mg | Drug | SP-304 3.0 mg |
| SP-304 9.0 mgSP-304 9.0 mg | Drug | SP-304 9.0 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)
Incidences of adverse events from Baseline through the end of the Follow-up period.
4 secondary outcomes
Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
Time frame: Study days 1 through 14
Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
Time frame: Study Days 1 through 14
Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
Time frame: Study day 1 through 14
Changes From Baseline Overall in Ease of Passage (Straining)
Time frame: Study Days 1 through 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationShailubhai K, Talluto C, Comiskey S, Foss J, Joslyn A, Jacob G. Phase II Clinical Evaluation of SP-304, a Guanylate Cyclase-C Agonist, for Treatment of Chronic Constipation. Am J Gastroenterology 105 (Supp 1): S487, 2010
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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.
Gary S Jacob, Ph.D. study director
Synergy Pharmaceuticals Inc.
14 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-304 0.3 mg, SP-304 1.0 mg and SP-304 3.0 mg in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 14 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 3 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (time frame: 21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053962, which also lists 1 linked publication.
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 2 Jan 2020.