Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01919697
Collaborator
Syneos Health (Other)
2,370
220
2
31
10.8
0.3
Study Details
Study Description
Brief Summary
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).
The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.
Study Design
Study Type:
Interventional
Actual Enrollment
:
2370 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
Study Start Date
:
Aug 1, 2013
Actual Primary Completion Date
:
Jan 1, 2016
Actual Study Completion Date
:
Mar 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Plecanatide 3.0 mg Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks |
Drug: Plecanatide
|
| Experimental: Plecanatide 6.0 mg Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks |
Drug: Plecanatide
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) [From first dose up to 72 weeks]
All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.
- Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide [From first dose up to 72 weeks]
Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug
- Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) [From first dose up to 72 weeks]
The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).
- Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) [From first dose up to 72 weeks]
The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).
- Summary of Vital Signs at >Day 364 - Body Temperature (°C) [From first dose up to 72 weeks]
The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).
- Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) [From first dose up to 72 weeks]
The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).
- Summary of ECG Results Shift From Baseline at > Day 364 [From first dose up to 72 weeks]
Baseline was defined as the last non-missing value collected prior to first dose of study drug)
- Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline [From first dose up to 72 weeks]
Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.
Secondary Outcome Measures
- Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 [Form first dose up to 72 weeks]
Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.
- Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 [From first dose up to 72 weeks]
Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.
- Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 [From first dose up to 72 weeks]
Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.
- Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment [From first dose up to 72 weeks]
Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 81 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
-
Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.
Exclusion Criteria:
-
Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
-
Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
-
Patient has taken a protocol-prohibited drug without the appropriate washout period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Synergy Research Site | Birmingham | Alabama | United States | 35242 |
| 2 | Synergy Research Site | Dothan | Alabama | United States | 36305 |
| 3 | Synergy Research Site | Gulf Shores | Alabama | United States | 36542 |
| 4 | Synergy Research Site | Huntsville | Alabama | United States | 35801 |
| 5 | Synergy Research Site | Chandler | Arizona | United States | 85224 |
| 6 | Synergy Research Site | Phoenix | Arizona | United States | 85018 |
| 7 | Synergy Research Site | Tempe | Arizona | United States | 85283 |
| 8 | Synergy Research Site | Tucson | Arizona | United States | 85704 |
| 9 | Synergy Research Site | Tucson | Arizona | United States | 85712 |
| 10 | Synergy Research Site | Tucson | Arizona | United States | 85716 |
| 11 | Synergy Research Site | Little Rock | Arkansas | United States | 72211 |
| 12 | Synergy Research Site | North Little Rock | Arkansas | United States | 72117 |
| 13 | Synergy Research Site | Anaheim | California | United States | 92801 |
| 14 | Synergy Research Site | Anaheim | California | United States | 92804 |
| 15 | Synergy Research Site | Artesia | California | United States | 90701 |
| 16 | Synergy Research Site | Carlsbad | California | United States | 92008 |
| 17 | Synergy Research Site | Cerritos | California | United States | 90703 |
| 18 | Synergy Research Site | Chula Vista | California | United States | 91910 |
| 19 | Synergy Research Site | Corona | California | United States | 92879 |
| 20 | Synergy Research Site | Encinitas | California | United States | 92024 |
| 21 | Synergy Research Site | Fountain Valley | California | United States | 92708 |
| 22 | Synergy Research Site | Fresno | California | United States | 93726 |
| 23 | Synergy Research Site | Hawaiian Gardens | California | United States | 90716 |
| 24 | Synergy Research Site | La Mirada | California | United States | 90638 |
| 25 | Synergy Research Site | Laguna Hills | California | United States | 92653 |
| 26 | Synergy Research Site | Lancaster | California | United States | 93534 |
| 27 | Synergy Research Site | Long Beach | California | United States | 90806 |
| 28 | Synergy Research Site | Los Angeles | California | United States | 90015 |
| 29 | Synergy Research Site | Los Angeles | California | United States | 90045 |
| 30 | Synergy Research Site | Mission Hills | California | United States | 91345 |
| 31 | Synergy Research Site | North Hollywood | California | United States | 91606 |
| 32 | Synergy Research Site | Orange | California | United States | 92868 |
| 33 | Synergy Research Site | Pasadena | California | United States | 91105 |
| 34 | Synergy Research Site | Sacramento | California | United States | 95821 |
| 35 | Synergy Research Site | San Diego | California | United States | 92103 |
| 36 | Synergy Research Site | San Diego | California | United States | 92108 |
| 37 | Synergy Research Site | San Diego | California | United States | 92114 |
| 38 | Synergy Research Site | Thousand Oaks | California | United States | 91360 |
| 39 | Synergy Research Site | Colorado Springs | Colorado | United States | 80904 |
| 40 | Synergy Research Site | Colorado Springs | Colorado | United States | 80907 |
| 41 | Synergy Research Site | Colorado Springs | Colorado | United States | 80909 |
| 42 | Synergy Research Site | Denver | Colorado | United States | 80218 |
| 43 | Synergy Research Site | Denver | Colorado | United States | 80220 |
| 44 | Synergy Research Site | Denver | Colorado | United States | 80246 |
| 45 | Synergy Research Site | Littleton | Colorado | United States | 80128 |
| 46 | Synergy Research Site | Bristol | Connecticut | United States | 06010 |
| 47 | Synergy Research Site | Waterbury | Connecticut | United States | 06708 |
| 48 | Synergy Research Site | Boynton Beach | Florida | United States | 33426 |
| 49 | Synergy Research Site | Brandon | Florida | United States | 33511 |
| 50 | Synergy Research Site | Clearwater | Florida | United States | 33756 |
| 51 | Synergy Research Site | Clearwater | Florida | United States | 33759 |
| 52 | Synergy Research Site | Cutler Bay | Florida | United States | 33189 |
| 53 | Synergy Research Site | DeLand | Florida | United States | 32720 |
| 54 | Synergy Research Site | Fort Lauderdale | Florida | United States | 33306 |
| 55 | Synergy Research Site | Hialeah | Florida | United States | 33012 |
| 56 | Synergy Research Site | Hialeah | Florida | United States | 33013 |
| 57 | Synergy Research Site | Hialeah | Florida | United States | 33016 |
| 58 | Synergy Research Site | Homestead | Florida | United States | 33030 |
| 59 | Synergy Research Site | Jupiter | Florida | United States | 33458 |
| 60 | Synergy Research Site | Lakeland | Florida | United States | 33805 |
| 61 | Synergy Research Site | Miami Lakes | Florida | United States | 33016 |
| 62 | Synergy Research Site | Miami Springs | Florida | United States | 33166 |
| 63 | Synergy Research Site | Miami | Florida | United States | 33015 |
| 64 | Synergy Research Site | Miami | Florida | United States | 33032 |
| 65 | Synergy Research Site | Miami | Florida | United States | 33122 |
| 66 | Synergy Research Site | Miami | Florida | United States | 33125 |
| 67 | Synergy Research Site | Miami | Florida | United States | 33126 |
| 68 | Synergy Research Site | Miami | Florida | United States | 33130 |
| 69 | Synergy Research Site | Miami | Florida | United States | 33142 |
| 70 | Synergy Research Site | Miami | Florida | United States | 33144 |
| 71 | Synergy Research Site | Miami | Florida | United States | 33155 |
| 72 | Synergy Research Site | Miami | Florida | United States | 33165 |
| 73 | Synergy Research Site | Miami | Florida | United States | 33173 |
| 74 | Synergy Research Site | Miami | Florida | United States | 33174 |
| 75 | Synergy Research Site | Miami | Florida | United States | 33175 |
| 76 | Synergy Research Site | Miami | Florida | United States | 33176 |
| 77 | Synergy Research Site | Miami | Florida | United States | 33186 |
| 78 | Synergy Research Site | Orlando | Florida | United States | 32801 |
| 79 | Synergy Research Site | Orlando | Florida | United States | 32806 |
| 80 | Synergy Research Site | Orlando | Florida | United States | 32807 |
| 81 | Synergy Research Site | Pembroke Pines | Florida | United States | 33026 |
| 82 | Synergy Research Site | Port Orange | Florida | United States | 32129 |
| 83 | Synergy Research Site | Saint Petersburg | Florida | United States | 33709 |
| 84 | Synergy Research Site | Tamarac | Florida | United States | 33319 |
| 85 | Synergy Research Site | Tampa | Florida | United States | 33606 |
| 86 | Synergy Research Site | Tampa | Florida | United States | 33607 |
| 87 | Synergy Research Site | West Palm Beach | Florida | United States | 33409 |
| 88 | Synergy Research Site | Athens | Georgia | United States | 30606 |
| 89 | Synergy Research Site | Atlanta | Georgia | United States | 30342 |
| 90 | Synergy Research Site | Decatur | Georgia | United States | 30032 |
| 91 | Synergy Research Site | Decatur | Georgia | United States | 30033 |
| 92 | Synergy Research Site | Oakwood | Georgia | United States | 30566 |
| 93 | Synergy Research Site | Sandy Springs | Georgia | United States | 30328 |
| 94 | Synergy Research Site | Savannah | Georgia | United States | 31406 |
| 95 | Synergy Research Site | Smyrna | Georgia | United States | 30082 |
| 96 | Synergy Research Site | Snellville | Georgia | United States | 30078 |
| 97 | Synergy Research Site | Blackfoot | Idaho | United States | 83221 |
| 98 | Synergy Research Site | Chicago | Illinois | United States | 60602 |
| 99 | Synergy Research Site | Brownsburg | Indiana | United States | 46112 |
| 100 | Synergy Research Site | Clive | Iowa | United States | 50325 |
| 101 | Synergy Research Site | Augusta | Kansas | United States | 67010 |
| 102 | Synergy Research Site | Newton | Kansas | United States | 67114 |
| 103 | Synergy Research Site | Shawnee Mission | Kansas | United States | 66218 |
| 104 | Synergy Research Site | Wichita | Kansas | United States | 67205 |
| 105 | Synergy Research Site | Wichita | Kansas | United States | 67207 |
| 106 | Synergy Research Site | Lexington | Kentucky | United States | 40503 |
| 107 | Synergy Research Site | Owensboro | Kentucky | United States | 42303 |
| 108 | Synergy Research Site | Bastrop | Louisiana | United States | 71220 |
| 109 | Synergy Research Site | Marrero | Louisiana | United States | 70072 |
| 110 | Synergy Research Site | Metairie | Louisiana | United States | 70006 |
| 111 | Synergy Research Site | New Orleans | Louisiana | United States | 70115 |
| 112 | Synergy Research Site | New Orleans | Louisiana | United States | 70119 |
| 113 | Synergy Research Site | Shreveport | Louisiana | United States | 71103 |
| 114 | Synergy Research Site | Chevy Chase | Maryland | United States | 20815 |
| 115 | Synergy Research Site | Boston | Massachusetts | United States | 02131 |
| 116 | Synergy Research Site | New Bedford | Massachusetts | United States | 02740 |
| 117 | Synergy Research Site | Chesterfield | Michigan | United States | 48047 |
| 118 | Synergy Research Site | Flint | Michigan | United States | 48504 |
| 119 | Synergy Research Site | Rochester | Michigan | United States | 48307 |
| 120 | Synergy Research Site | Saginaw | Michigan | United States | 48604 |
| 121 | Synergy Research Site | Southfield | Michigan | United States | 48034 |
| 122 | Synergy Research Site | Biloxi | Mississippi | United States | 39531 |
| 123 | Synergy Research Site | Jackson | Mississippi | United States | 39202 |
| 124 | Synergy Research Site | Saint Louis | Missouri | United States | 63128 |
| 125 | Synergy Research Site | Grand Island | Nebraska | United States | 68803 |
| 126 | Synergy Research Site | Omaha | Nebraska | United States | 68114 |
| 127 | Synergy Research Site | Henderson | Nevada | United States | 89014 |
| 128 | Synergy Research Site | Las Vegas | Nevada | United States | 89103 |
| 129 | Synergy Research Site | Las Vegas | Nevada | United States | 89119 |
| 130 | Synergy Research Site | Las Vegas | Nevada | United States | 89121 |
| 131 | Synergy Research Site | Reno | Nevada | United States | 89511 |
| 132 | Synergy Research Site | Elizabeth | New Jersey | United States | 07202 |
| 133 | Synergy Research Site | Lodi | New Jersey | United States | 07644 |
| 134 | Synergy Research Site | Marlton | New Jersey | United States | 08053 |
| 135 | Synergy Research Site | Albuquerque | New Mexico | United States | 87108 |
| 136 | Synergy Research Site | Albuquerque | New Mexico | United States | 87109 |
| 137 | Synergy Research Site | Brooklyn | New York | United States | 11206 |
| 138 | Synergy Research Site | Great Neck | New York | United States | 11023 |
| 139 | Synergy Research Site | New York | New York | United States | 10016 |
| 140 | Synergy Research Site | Poughkeepsie | New York | United States | 12601 |
| 141 | Synergy Research Site | Cary | North Carolina | United States | 27518 |
| 142 | Synergy Research Site | Chapel Hill | North Carolina | United States | 27599 |
| 143 | Synergy Research Site | Charlotte | North Carolina | United States | 28210 |
| 144 | Synergy Research Site | Charlotte | North Carolina | United States | 28277 |
| 145 | Synergy Research Site | Greensboro | North Carolina | United States | 27403 |
| 146 | Synergy Research Site | Kinston | North Carolina | United States | 28501 |
| 147 | Synergy Research Site | Raleigh | North Carolina | United States | 27612 |
| 148 | Synergy Research Site | Wilmington | North Carolina | United States | 28401 |
| 149 | Synergy Research Site | Winston-Salem | North Carolina | United States | 27103 |
| 150 | Synergy Research Site | Fargo | North Dakota | United States | 58103 |
| 151 | Synergy Research Site | Beavercreek | Ohio | United States | 45432 |
| 152 | Synergy Research Site | Centerville | Ohio | United States | 45459 |
| 153 | Synergy Research Site | Cincinnati | Ohio | United States | 45224 |
| 154 | Synergy Research Site | Cincinnati | Ohio | United States | 45246 |
| 155 | Synergy Research Site | Cleveland | Ohio | United States | 44122 |
| 156 | Synergy Research Site | Huber Heights | Ohio | United States | 45424 |
| 157 | Synergy Research Site | Maumee | Ohio | United States | 43537 |
| 158 | Synergy Research Site | Mentor | Ohio | United States | 44060 |
| 159 | Synergy Research Site | Oakwood | Ohio | United States | 45419 |
| 160 | Synergy Research Site | Stow | Ohio | United States | 44224 |
| 161 | Synergy Research Site | Norman | Oklahoma | United States | 73071 |
| 162 | Synergy Research Site | Oklahoma City | Oklahoma | United States | 73102 |
| 163 | Synergy Research Site | Oklahoma City | Oklahoma | United States | 73104 |
| 164 | Synergy Research Site | Levittown | Pennsylvania | United States | 19056 |
| 165 | Synergy Research Site | Limerick | Pennsylvania | United States | 19468 |
| 166 | Synergy Research Site | Philadelphia | Pennsylvania | United States | 19152 |
| 167 | Synergy Research Site | Pittsburgh | Pennsylvania | United States | 15206 |
| 168 | Synergy Research Site | Yardley | Pennsylvania | United States | 19067 |
| 169 | Synergy Research Site | Anderson | South Carolina | United States | 29621 |
| 170 | Synergy Research Site | Charleston | South Carolina | United States | 29406 |
| 171 | Synergy Research Site | Columbia | South Carolina | United States | 29203 |
| 172 | Synergy Research Site | Chattanooga | Tennessee | United States | 37421 |
| 173 | Synergy Research Site | Franklin | Tennessee | United States | 37064 |
| 174 | Synergy Research Site | Jackson | Tennessee | United States | 38305 |
| 175 | Synergy Research Site | Knoxville | Tennessee | United States | 37912 |
| 176 | Synergy Research Site | Memphis | Tennessee | United States | 38119 |
| 177 | Synergy Research Site | Nashville | Tennessee | United States | 37211 |
| 178 | Synergy Research Site | New Tazewell | Tennessee | United States | 37825 |
| 179 | Synergy Research Site | Arlington | Texas | United States | 76012 |
| 180 | Synergy Research Site | Austin | Texas | United States | 78731 |
| 181 | Synergy Research Site | Austin | Texas | United States | 78745 |
| 182 | Synergy Research Site | Channelview | Texas | United States | 77530 |
| 183 | Synergy Research Site | Dallas | Texas | United States | 75230 |
| 184 | Synergy Research Site | Dallas | Texas | United States | 75234 |
| 185 | Synergy Research Site | Houston | Texas | United States | 77034 |
| 186 | Synergy Research Site | Houston | Texas | United States | 77043 |
| 187 | Synergy Research Site | Houston | Texas | United States | 77062 |
| 188 | Synergy Research Site | Houston | Texas | United States | 77070 |
| 189 | Synergy Research Site | Houston | Texas | United States | 77090 |
| 190 | Synergy Research Site | Houston | Texas | United States | 77099 |
| 191 | Synergy Research Site | Humble | Texas | United States | 77338 |
| 192 | Synergy Research Site | Katy | Texas | United States | 77450 |
| 193 | Synergy Research Site | Plano | Texas | United States | 75093 |
| 194 | Synergy Research Site | San Antonio | Texas | United States | 78209 |
| 195 | Synergy Research Site | San Antonio | Texas | United States | 78215 |
| 196 | Synergy Research Site | Sugar Land | Texas | United States | 77479 |
| 197 | Synergy Research Site | Logan | Utah | United States | 84341 |
| 198 | Synergy Research Site | Saint George | Utah | United States | 84790 |
| 199 | Synergy Research Site | Salt Lake City | Utah | United States | 84124 |
| 200 | Synergy Research Site | West Jordan | Utah | United States | 84088 |
| 201 | Synergy Research Site | Christiansburg | Virginia | United States | 24073 |
| 202 | Synergy Research Site | Henrico | Virginia | United States | 23233 |
| 203 | Synergy Research Site | Lynchburg | Virginia | United States | 24502 |
| 204 | Synergy Research Site | Newport News | Virginia | United States | 23606 |
| 205 | Synergy Research Site | Norfolk | Virginia | United States | 23502 |
| 206 | Synergy Research Site | Norfolk | Virginia | United States | 23507 |
| 207 | Synergy Research Site | Richmond | Virginia | United States | 23294 |
| 208 | Synergy Research Site | Richland | Washington | United States | 99352 |
| 209 | Synergy Research Site | Seattle | Washington | United States | 98105 |
| 210 | Synergy Research Site | Tacoma | Washington | United States | 98405 |
| 211 | Synergy Research Site | Wauwatosa | Wisconsin | United States | 53226 |
| 212 | Synergy Research Site | Kelowna | British Columbia | Canada | V1Y 1Z9 |
| 213 | Synergy Research Site | Bridgewater | Nova Scotia | Canada | B4V 3N2 |
| 214 | Synergy Research Site | Cambridge | Ontario | Canada | N1S 2M6 |
| 215 | Synergy Research Site | Sudbury | Ontario | Canada | P3A 1Y8 |
| 216 | Synergy Research Site | Toronto | Ontario | Canada | M3J 2C5 |
| 217 | Synergy Research Site | Toronto | Ontario | Canada | M9W 4L6 |
| 218 | Synergy Research Site | Mirabel | Quebec | Canada | J7J 2K8 |
| 219 | Synergy Research Site | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 220 | Synergy Research Site | St-Romuald | Quebec | Canada | G6W 5M6 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
- Syneos Health
Investigators
- Principal Investigator: Richard A Krause, MD, ClinSearch, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT01919697
Other Study ID Numbers:
- SP304203-01
First Posted:
Aug 9, 2013
Last Update Posted:
Jul 2, 2019
Last Verified:
Jun 1, 2019
Keywords provided by Bausch Health Americas, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients with CIC who completed the double-blind phase 2b (NCT01429987) study, or phase 3 (NCT01982240 or NCT0222471) studies or who screen-failed for the phase 3 studies due solely to pre-treatment diary compliance and met all of the inclusion criteria and none of the exclusion criteria enrolled into this open-label study. |
|---|---|
| Pre-assignment Detail | A total of 2370 enrolled patients who had received at least one dose of the study drug constituted the Safety Population. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for up to 72 weeks |
| Period Title: Overall Study | ||
| STARTED | 224 | 2146 |
| COMPLETED | 171 | 1761 |
| NOT COMPLETED | 53 | 385 |
Baseline Characteristics
| Arm/Group Title | Plecanatide 3 mg | Plecanatide 6 mg | Total |
|---|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for up to 72 weeks | Total of all reporting groups |
| Overall Participants | 224 | 2097 | 2321 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
48.9
(11.78)
|
46.8
(14.03)
|
47.0
(13.84)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
190
84.8%
|
1687
80.4%
|
1877
80.9%
|
| Male |
34
15.2%
|
410
19.6%
|
444
19.1%
|
Outcome Measures
| Title | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) |
|---|---|
| Description | All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE. |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population consisted of all enrolled patients who had received at least one dose of the study drug. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Count of Participants [Participants] |
123
54.9%
|
620
29.6%
|
| Title | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide |
|---|---|
| Description | Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population consisted of all enrolled patients who had at least one dose of the study drug. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Count of Participants [Participants] |
14
6.3%
|
111
5.3%
|
| Title | Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) |
|---|---|
| Description | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Systolic Blood Pressure |
121
(13.40)
|
122.9
(14.11)
|
| Diastolic Blood Pressure |
75.7
(9.19)
|
76.5
(8.47)
|
| Title | Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) |
|---|---|
| Description | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [beats per minute] |
71.2
(10.03)
|
71.9
(9.30)
|
| Title | Summary of Vital Signs at >Day 364 - Body Temperature (°C) |
|---|---|
| Description | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [°C] |
36.62
(0.329)
|
36.59
(0.378)
|
| Title | Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) |
|---|---|
| Description | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for up to 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [breaths per minute] |
15.7
(2.03)
|
16.0
(2.31)
|
| Title | Summary of ECG Results Shift From Baseline at > Day 364 |
|---|---|
| Description | Baseline was defined as the last non-missing value collected prior to first dose of study drug) |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Change from Normal to Abnormal |
27
12.1%
|
42
2%
|
| Change from Adnormal to Normal |
15
6.7%
|
44
2.1%
|
| Title | Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline |
|---|---|
| Description | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE. |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Number [participants] |
192
85.7%
|
1498
71.4%
|
| Title | Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 |
|---|---|
| Description | Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. |
| Time Frame | Form first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [score on a scale] |
1.8
(0.94)
|
1.7
(0.89)
|
| Title | Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 |
|---|---|
| Description | Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled patients who had at least one dose of the study drug and had at least one post-baseline Patient Global Assessment (PGA) were included in this population. A total of 2378 patients including the re-enrolled patients who previously participated and completed this open-label study was used for assessments. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [score on a scale] |
1.8
(0.94)
|
1.7
(0.89)
|
| Title | Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 |
|---|---|
| Description | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied. |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [score on a scale] |
4.1
(1.13)
|
4.2
(1.02)
|
| Title | Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment |
|---|---|
| Description | Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely |
| Time Frame | From first dose up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. |
| Arm/Group Title | Plecanatide 3 mg | Plecantide 6 mg |
|---|---|---|
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks |
| Measure Participants | 224 | 2146 |
| Measure Readings | 224 | 2154 |
| Mean (Standard Deviation) [score on a scale] |
4.1
(1.22)
|
4.1
(1.16)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | All enrolled patients (2370) who received at least one dose of study drug was included in the risk analysis. There was one death, unrelated to study drug, reported in this study; the patient died from a myocardial infarction (MI) that was related to a cocaine-induced coronary vasopasm. | |||
| Arm/Group Title | Plecanatide 3 mg | Plecanatide 6 mg | ||
| Arm/Group Description | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks | ||
All Cause Mortality |
||||
| Plecanatide 3 mg | Plecanatide 6 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/224 (0%) | 1/2146 (0%) | ||
Serious Adverse Events |
||||
| Plecanatide 3 mg | Plecanatide 6 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/224 (3.6%) | 32/2146 (1.5%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 1/224 (0.4%) | 1 | 1/2146 (0%) | 1 |
| Myocardial infarction | 0/224 (0%) | 0 | 1/2146 (0%) | 2 |
| Cardiac failure congestive | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Gastrointestinal disorders | ||||
| Gastrooesophageal reflux disease | 1/224 (0.4%) | 1 | 1/2146 (0%) | 1 |
| Abdominal pain | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Vomiting | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| General disorders | ||||
| Non-cardiac chest pain | 0/224 (0%) | 0 | 2/2146 (0.1%) | 2 |
| Hepatobiliary disorders | ||||
| Bile duct stone | 1/224 (0.4%) | 1 | 0/2146 (0%) | 0 |
| Cholecystitis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Cholelithiasis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Immune system disorders | ||||
| Drug hypersensitivity | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Infections and infestations | ||||
| Diverticulitis | 2/224 (0.9%) | 2 | 0/2146 (0%) | 0 |
| Appendicitis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Clostridium difficile colitis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Gastroenteritis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Liver abscess | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Femoral neck fracture | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Patella fracture | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Rib fracture | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Tendon injury | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Investigations | ||||
| Alanine aminotransferase increased | 0/224 (0%) | 0 | 2/2146 (0.1%) | 2 |
| Aspartate aminotransferase abnormal | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Aspartate aminotransferase increased | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Electrocardiogram change | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bladder cancer | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Non-Hodgkin's lymphoma | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Ovarian adenoma | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Nervous system disorders | ||||
| Ischaemic stroke | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 1/224 (0.4%) | 1 | 7/2146 (0.3%) | 7 |
| Abortion spontaneous | 1/224 (0.4%) | 1 | 1/2146 (0%) | 1 |
| Psychiatric disorders | ||||
| Psychotic disorder | 1/224 (0.4%) | 1 | 0/2146 (0%) | 0 |
| Renal and urinary disorders | ||||
| Calculus ureteric | 1/224 (0.4%) | 1 | 0/2146 (0%) | 0 |
| Hydronephrosis | 1/224 (0.4%) | 1 | 0/2146 (0%) | 0 |
| Nephrolithiasis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Renal failure acute | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumothorax | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
| Vascular disorders | ||||
| Hypotension | 1/224 (0.4%) | 1 | 0/2146 (0%) | 0 |
| Thrombosis | 0/224 (0%) | 0 | 1/2146 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Plecanatide 3 mg | Plecanatide 6 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/224 (14.3%) | 188/2146 (8.8%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 19/224 (8.5%) | 24 | 150/2146 (7%) | 159 |
| Infections and infestations | ||||
| Urinary tract infection | 13/224 (5.8%) | 15 | 38/2146 (1.8%) | 40 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Patrick H. Griffin |
|---|---|
| Organization | Synergy Pharmaceuticals Inc. |
| Phone | 212-297-0020 |
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT01919697
Other Study ID Numbers:
- SP304203-01
First Posted:
Aug 9, 2013
Last Update Posted:
Jul 2, 2019
Last Verified:
Jun 1, 2019