| 1 |
NCT03316859 |
Recruiting |
Naloxegol and Opioid-induced Constipation |
- Constipation
- Constipation Drug Induced
|
- Drug: Naloxegol 25 MG
- Other: Placebo pill
|
Interventional |
Phase 2
Phase 3 |
- Angela Fellner
- TriHealth Inc.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to substantial bowel movement
- Rescue medications
|
280 |
All |
18 Years and older (Adult, Senior) |
NCT03316859 |
17-020 |
|
November 6, 2017 |
October 2, 2018 |
October 2, 2018 |
October 20, 2017 |
November 9, 2017 |
|
- Bethesda North TriHealth Hospital
Cincinnati, Ohio, United States
|
| 2 |
NCT02745353 |
Recruiting |
Naloxegol in Cancer Opioid-Induced Constipation |
|
|
Interventional |
Phase 2 |
- University of California, San Diego
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02745353 |
160121 |
|
May 2016 |
April 2020 |
April 2021 |
April 20, 2016 |
March 1, 2017 |
|
- UCSD Moores Cancer Center
La Jolla, California, United States
|
| 3 |
NCT03177434 |
Recruiting |
Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years. |
|
- Drug: polyethylene glycols (PEG) 3350
- Drug: Lactulose Oral Product
|
Interventional |
Phase 4 |
- Children's Memorial Health Institute, Poland
- Medical University of Bialystok
- University of Rzeszow
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years.
|
102 |
All |
6 Months to 6 Years (Child) |
NCT03177434 |
IPCZD 27.01.2016 |
|
February 2016 |
May 2018 |
May 2018 |
June 6, 2017 |
June 6, 2017 |
|
- Department of Pediatrics, Gastroenterology and Allergology; Medical University of Bialystok
Bialystok, Poland - University of Rzeszow
Rzeszow, Poland - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics; The Childrens Memorial Health Institute
Warsaw, Poland
|
| 4 |
NCT02795390 |
Recruiting |
Clinical Trial on Palliative Cancer Patients With Constipation |
|
- Drug: Chinese herbal medicine
- Drug: Placebo
|
Interventional |
Phase 2 |
- Hong Kong Baptist University
- Caritas Medical Centre
- Yan Chai Hospital
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Global symptom improvement (improved / same / worse)
- Number of bowel movement (times/day)
- Stool form
- (and 8 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02795390 |
HKBU/KWC/PC2014 |
|
November 2016 |
November 2018 |
November 2018 |
June 10, 2016 |
August 9, 2017 |
|
- Caritas Medical Centre
Hong Kong, Hong Kong - Hong Kong Buddhist Hospital
Hong Kong, Hong Kong - Our Lady of Maryknoll Hospital
Hong Kong, Hong Kong
|
| 5 |
NCT02977858 |
Recruiting |
ISE to Support Constipation Management |
|
- Other: Educational practice for HCPs,Dissemination only
- Other: Educational practice for HCPs,Spaced Education
|
Observational |
|
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Patient Referral
- Improved knowledge gains
- Improved adherence to Constipation Management Guideline
|
160 |
All |
Child, Adult, Senior |
NCT02977858 |
2015-9317 |
|
August 2016 |
August 2018 |
August 2019 |
November 30, 2016 |
November 30, 2016 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
| 6 |
NCT03391635 |
Not yet recruiting |
Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation |
|
- Device: Electroacupuncture
- Device: TranscutaneousElectricNerveStimulation
|
Interventional |
Not Applicable |
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
- The proportion of participants with an average increasing of one or more complete spontaneous bowel movements
- Change number in CSBMS
- (and 5 more...)
|
102 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03391635 |
GAMHospital20171222 |
|
July 2018 |
December 2019 |
December 2020 |
January 5, 2018 |
April 18, 2018 |
|
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, China
|
| 7 |
NCT02877394 |
Recruiting |
Use of a Squatting Assist Device in Patients With Constipation |
|
- Device: Squatting Assist Device
- Device: Sham Squatting Assist Device
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
|
85 |
Female |
18 Years to 80 Years (Adult, Senior) |
NCT02877394 |
16-004548 |
|
September 2016 |
September 2018 |
September 2018 |
August 24, 2016 |
July 7, 2017 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 8 |
NCT03243955 |
Recruiting |
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation |
- Constipation - Functional
|
- Device: Verum TEAS
- Device: Sham TEAS
|
Interventional |
Not Applicable |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- spontaneous bowel movement (SBMs) per week
- Responder rate
- PAC-QOL
- (and 3 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03243955 |
441356-KH-50890 |
|
February 28, 2017 |
February 27, 2018 |
February 26, 2019 |
August 9, 2017 |
August 10, 2017 |
|
- University of California, Los Angeles
Los Angeles, California, United States
|
| 9 |
NCT02946580 |
Recruiting |
Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients |
|
- Drug: MOVANTIK™ (naloxegol)
- Drug: Sugar Pill
|
Interventional |
Phase 4 |
- Massachusetts General Hospital
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Time to first post-operative spontaneous bowel movement
- Number of uses of rescue laxative medication during hospitalization
- Length of stay
- (and 3 more...)
|
186 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02946580 |
2016P001847
ESR-15-11338, D3820L00008 |
|
January 2017 |
January 2018 |
January 2018 |
October 27, 2016 |
February 8, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 10 |
NCT02526849 |
Recruiting |
Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation |
- Slow Transit Constipation
|
- Drug: Fecal microbiota transplantation (FMT)
- Behavioral: Conventional treatment
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Proportion of patients having on average three or more SCBMs/week
- Mean number of bowel movements per week
- Characteristics of bowel movements
- (and 5 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02526849 |
RCT-FMT-STC-2015 |
|
November 2015 |
December 2016 |
June 2017 |
August 18, 2015 |
November 4, 2016 |
|
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
|
| 11 |
NCT03335969 |
Not yet recruiting |
HyGIeaCare Procedure for Chronic Constipation |
- Constipation - Functional
|
|
Interventional |
Not Applicable |
- HyGIeaCare, Inc.
- Biostatistical Consulting, Inc.
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in number of BMs
- Change in constipation score and discomfort score (GISSI)
- Change in rescue medications used
|
40 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03335969 |
HGP-0003 |
|
November 20, 2017 |
November 1, 2018 |
December 30, 2018 |
November 8, 2017 |
November 8, 2017 |
|
- Mayo Clinic
Scottsdale, Arizona, United States
|
| 12 |
NCT03333070 |
Not yet recruiting |
The Use of Lactobacillus Reuteri in Functional Constipation in Children |
|
- Dietary Supplement: probiotic - Lactobacillus reuteri
- Other: placebo - with no active ingredient
|
Interventional |
Not Applicable |
- HaEmek Medical Center, Israel
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The prevalence of constipation recurrence
- failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment
- The number of bowel movements per week
- (and 2 more...)
|
50 |
All |
6 Months to 15 Years (Child) |
NCT03333070 |
0042-17-EMC |
|
October 2018 |
October 2019 |
October 2019 |
November 6, 2017 |
March 8, 2018 |
|
|
| 13 |
NCT02559570 |
Recruiting |
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC) |
- Functional Constipation in Children Ages 6-17 Years
|
- Drug: Linaclotide Dose A
- Drug: Linaclotide Dose B
- Drug: Linaclotide Dose C
- (and 2 more...)
|
Interventional |
Phase 2 |
- Forest Laboratories
- Ironwood Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in 4-week overall spontaneous bowel movement (SBM) frequency rate (SBMs/week) during the Treatment Period
- Change from baseline in 4-week stool consistency
- Change from baseline in 4-week severity of straining
- (and 2 more...)
|
160 |
All |
6 Years to 17 Years (Child) |
NCT02559570 |
LIN-MD-62 |
LIN-MD-62 |
November 1, 2015 |
September 8, 2018 |
September 8, 2018 |
September 24, 2015 |
February 27, 2018 |
|
- HealthStar Research, LLC
Hot Springs, Arkansas, United States - Applied Research Center of Arkansas
Little Rock, Arkansas, United States - Advanced Research Center
Anaheim, California, United States - (and 71 more...)
|
| 14 |
NCT02984969 |
Recruiting |
Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients |
- Slow Transit Constipation
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Fecal microbiota sequence
- Stool short-chain fatty acids (SCFAs)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02984969 |
STC-2016-16sRNA |
|
July 2016 |
November 2016 |
February 2017 |
December 7, 2016 |
December 7, 2016 |
|
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
|
| 15 |
NCT02381665 |
Not yet recruiting |
Efficacy of Interferential Therapy in Chronic Constipation (CON-COUR) |
- Chronic Constipation Symptoms
|
- Device: Flexstim IF
- Device: Flexstim IF faked
|
Interventional |
Not Applicable |
- Assistance Publique Hopitaux De Marseille
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02381665 |
2014-14
2014-A01359-38 |
CON-COUR |
March 2015 |
March 2018 |
March 2019 |
March 6, 2015 |
March 6, 2015 |
|
|
| 16 |
NCT03120520 |
Recruiting |
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation |
- Chronic Idiopathic Constipation
|
- Drug: Plecanatide
- Drug: Matching placebo
|
Interventional |
Phase 2 |
- Synergy Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of Responders for the last 2 weeks of the Treatment Period (responder = a child who experiences >3 Spontaneous Bowel Movements per week for each of the last two weeks of the treatment period) compared to placebo and across treatment groups
- Change from baseline in weekly average stool consistency Bristol Stool Form Scale (BSFS) score, by study week
- Change from baseline in the weekly rate of Spontaneous Bowel Movements (SBM), by study week
- Change from baseline in the weekly rate of Complete Spontaneous Bowel Movements (CSBM), by study week
|
120 |
All |
12 Years to 17 Years (Child) |
NCT03120520 |
SP304202-13 |
|
January 2017 |
September 2018 |
September 2018 |
April 19, 2017 |
April 13, 2018 |
|
- Synergy Research Site
Foley, Alabama, United States - Synergy Research Site
Jonesboro, Arkansas, United States - Synergy Research Site
Cerritos, California, United States - (and 33 more...)
|
| 17 |
NCT03096704 |
Recruiting |
Vitamine d Dosage and Constipation |
- Vitamine d Dosage in Slow Transit Time Constipation
|
- Diagnostic Test: vitamine d dosage
|
Observational |
|
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
50 |
All |
17 Years to 75 Years (Child, Adult, Senior) |
NCT03096704 |
29 |
|
January 30, 2017 |
April 30, 2017 |
May 15, 2017 |
March 30, 2017 |
March 31, 2017 |
|
- Alba Panarese
Noci, Puglia, Italy
|
| 18 |
NCT02751411 |
Recruiting |
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months |
- Chronic Functional Constipation
|
- Device: micro-enema with Promelaxin
- Drug: Macrogol 4000
|
Interventional |
Phase 4 |
- Aboca Spa Societa' Agricola
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
- score of the parents quality of life calculated on day 21 and 56
- score of the children quality of life calculated on day 21 and 56
- (and 4 more...)
|
120 |
All |
6 Months to 48 Months (Child) |
NCT02751411 |
ABO-MELI-15 |
|
April 18, 2016 |
May 2018 |
September 2018 |
April 26, 2016 |
January 29, 2018 |
|
- ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
L'Aquila, AQ, Italy - Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
Pavia, PV, Italy - Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
Napoli, Italy - AOU Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, Italy
|
| 19 |
NCT03226145 |
Recruiting |
Reclassifying Constipation Using Imaging and Manometry |
- Constipation - Functional
- Irritable Bowel Syndrome Characterized by Constipation
|
- Procedure: MRI Motility
- Procedure: High Resolution Manometry
- Drug: Bisacodyl
- Drug: Hyoscine butylbromide
|
Interventional |
Not Applicable |
- University of Nottingham
- University College, London
- Queen Mary University of London
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- MRI Endpoint: Maximal MRI Motility Index (MMI) of the ascending colon (AC)
- HRM Endpoint: Percentage time occupied by cyclical propagating activity following meal
- Difference in average worst daily pain, scored on a range 1-5 between buscopan and bisacodyl intervention periods.
- (and 7 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT03226145 |
16105 |
RECLAIM |
July 20, 2017 |
June 2019 |
June 2019 |
July 21, 2017 |
April 17, 2018 |
|
- University of Nottingham
Nottingham, Notts, United Kingdom - Queen Mary University of London
London, United Kingdom - University College London
London, United Kingdom
|
| 20 |
NCT02961582 |
Recruiting |
Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation |
|
- Device: Sacral Neuromodulation
- Other: Personalized Conservative Treatment
|
Interventional |
Phase 4 |
- Maastricht University Medical Center
- Dutch Healthcare Institute (Zorginstituut Nederland)
- Medtronic
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment success at 6 months
- Defecation frequency
- Proportion of patients with a 50% reduction in the proportion of defecations with straining
- (and 9 more...)
|
64 |
All |
14 Years to 80 Years (Child, Adult, Senior) |
NCT02961582 |
NL57367.068.16 |
|
November 2016 |
December 2019 |
March 2021 |
November 11, 2016 |
March 20, 2018 |
|
- Maastricht University Medical Centre
Maastricht, Limburg, Netherlands - Groene Hart Ziekenhuis
Gouda, Zuid-Holland, Netherlands
|
| 21 |
NCT02842411 |
Recruiting |
Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation |
|
|
Observational |
|
- Fourth Military Medical University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- adequate rate of bowel preparation ≥6 with each segment ≥2
- polyp detection rate
- insertion time
- withdrawal time
|
200 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02842411 |
20160616-5 |
|
August 2016 |
January 2017 |
January 2017 |
July 22, 2016 |
November 1, 2016 |
|
- The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China - Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China - Tangdu Hospital
Xi'an, Shaanxi, China - Chinese PLA 451 Hospital
Xi'an, Shaanxi, China
|
| 22 |
NCT02705378 |
Not yet recruiting |
The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit |
- Constipation
- Critical Illness
|
- Drug: Polyethylene glycol
- Drug: naloxegol
|
Interventional |
Phase 3 |
- Massachusetts General Hospital
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Laxation within 48 hours of starting second-line agent
- Time to first bowel movement after starting second-line agent
- Doses of second-line laxative agent before bowel movement
- (and 2 more...)
|
350 |
All |
18 Years and older (Adult, Senior) |
NCT02705378 |
NaRC-ICU_temp |
NaRC-ICU |
May 2017 |
April 2019 |
December 2019 |
March 10, 2016 |
March 30, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 23 |
NCT03148002 |
Recruiting |
Peritoneal Dialysis Pilot Study: Evaluating Polyethylene Glycol (PEG) for Constipation |
- Constipation
- Peritoneal Dialysis Complication
|
- Drug: Current Bowel Protocol (senna/lactulose)
- Drug: PEG Bowel Protocol (PEG/lactulose)
|
Interventional |
Phase 4 |
- Jaclyn Tran
- Nova Scotia Health Authority
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of constipation treatment success
- Number of patients with laxative related adverse effects.
- Mean change from baseline on the PAC-SYM questionnaire
- (and 2 more...)
|
30 |
All |
Child, Adult, Senior |
NCT03148002 |
PDBowel2017 |
|
July 7, 2017 |
November 1, 2017 |
February 1, 2018 |
May 10, 2017 |
July 19, 2017 |
|
- Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, Canada
|
| 24 |
NCT03186079 |
Recruiting |
Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Constipation |
- Constipation
- Chinese Herbal Medicine
|
- Drug: Xiaojidaozhi Decoction oral capsules
- Drug: Placebo oral capsules
- Drug: Fiberform
- Behavioral: Toilet training
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Percentage of overall efficacy
- Baseline of constipation score in the beginning of treatment
- Change of constipation score from the baseline in the end of treatment
- (and 2 more...)
|
200 |
All |
4 Years to 14 Years (Child) |
NCT03186079 |
A333-2 |
|
May 1, 2017 |
February 2018 |
March 2018 |
June 14, 2017 |
July 17, 2017 |
|
- Shengjing Hospital
Shenyang, Liaoning, China
|
| 25 |
NCT02559817 |
Recruiting |
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation |
- Irritable Bowel Syndrome With Constipation
|
- Drug: Linaclotide Dose A
- Drug: Linaclotide Dose B
- Drug: Linaclotide Dose C
- (and 2 more...)
|
Interventional |
Phase 2 |
- Forest Laboratories
- Ironwood Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in 4-week overall spontaneous bowel movement (SBM) frequency rate (SBMs/week) during the Treatment Period
- Change from baseline in 4-week abdominal pain daytime symptoms based on evening assessment of abdominal pain symptoms
- Change from baseline in 4-week stool consistency
- (and 3 more...)
|
260 |
All |
7 Years to 17 Years (Child) |
NCT02559817 |
LIN-MD-63 |
LIN-MD-63 |
November 1, 2015 |
October 18, 2020 |
October 18, 2020 |
September 24, 2015 |
February 26, 2018 |
|
- HealthStar Research, LLC
Hot Springs, Arkansas, United States - Applied Research Center of Arkansas
Little Rock, Arkansas, United States - Advanced Research Center - Site 069
Anaheim, California, United States - (and 59 more...)
|
| 26 |
NCT02854098 |
Recruiting |
The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children |
- Benign Hypermobility Syndrome
- Functional Constipation
|
|
Observational |
|
- Medical University of Warsaw
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- The comorbidity of benign hypermobility joint syndrome and functional constipation in children (in %)
- The comorbidity of BHJS and functional constipation, depending on age (in %)
- The comorbidity of BHJS and functional constipation, depending on gender (in %)
|
400 |
All |
3 Years to 18 Years (Child, Adult) |
NCT02854098 |
1W33 |
MobCon |
April 2015 |
June 2017 |
October 2017 |
August 3, 2016 |
March 31, 2017 |
|
- Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
Warsaw, Mazowieckie, Poland
|
| 27 |
NCT02566746 |
Recruiting |
Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment |
|
- Device: Chait Trapdoor caecostomie catheter
- Drug: continuation of optimal medical therapy
|
Interventional |
Not Applicable |
- Nantes University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Quality of life (Gastrointestinal Quality Of Life Index)
- Evolution of the Quality of life (SF-36 score)
- Constipation score (Kess score)
- (and 5 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02566746 |
RC15_0041 |
ConstiCAPE |
June 20, 2016 |
August 2019 |
August 2019 |
October 2, 2015 |
April 4, 2017 |
|
- CHU de Bordeaux
Bordeaux, France - CHU Clermont Ferrand
Clermont Ferrand, France - CHD Vendée
La Roche Sur Yon, France - (and 4 more...)
|
| 28 |
NCT03471728 |
Recruiting |
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation |
- Irritable Bowel Syndrome With Constipation (IBS-C)
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of diarrhea
- Safety assessed by incidence of adverse drug reactions
- Efficacy assessed by Global assessment of relief of IBS symptoms
|
1000 |
All |
Child, Adult, Senior |
NCT03471728 |
0456-MA-3141 |
|
October 2, 2017 |
December 2021 |
December 2021 |
March 21, 2018 |
March 21, 2018 |
|
- Site JP00023
Aichi, Japan - Site JP00005
Akita, Japan - Site JP00002
Aomori, Japan - (and 44 more...)
|
| 29 |
NCT02344485 |
Recruiting |
Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease |
- Parkinson's Disease
- Constipation
|
|
Interventional |
Not Applicable |
- New York Institute of Technology
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Constipation Scoring System (Cleveland Criteria)
- Bristol Stool Scale
- PAC-SYM©
- PAC-QOL©
|
20 |
All |
40 Years and older (Adult, Senior) |
NCT02344485 |
BHS-1065 |
|
January 2015 |
January 2019 |
January 2019 |
January 26, 2015 |
October 9, 2017 |
|
- New York Institute of Technology- Academic Health Care Center
Old Westbury, New York, United States
|
| 30 |
NCT03342287 |
Recruiting |
Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation |
- Constipation
- Irritable Bowel Syndrome
|
- Other: questionnaires
- Other: cognitive evaluation
- Other: Blood
- Other: Fecal sample
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To measure anxiety and depression using the Depression, Anxiety and Stress Scale (DASS) in patients with IBS-C and CIC before and after treatment with Linaclotide
- To measure neuropsychological performance in Patients with IBS-C and CIC using a standardized neuropsychological assessment in patients (CNS vital signs) before and after treatment with Linaclotide
- To determine changes in fecal microbiome profile before and after treatment with Linaclotide and whether these changes correlate with changes in psychiatric symptoms and cognition.
- To determine changes in inflammatory biomarker profile before and after treatment with Linaclotide and whether these changes correlate with changes in psychiatric symptoms and cognition.
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT03342287 |
1088 |
|
March 2016 |
December 2018 |
December 2018 |
November 14, 2017 |
December 11, 2017 |
|
- McMaster University Health Centre
Hamilton, Ontario, Canada
|
| 31 |
NCT03117322 |
Recruiting |
Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation |
- Cerebral Palsy
- Chronic Constipation
|
- Biological: agave inulin
- Biological: Lactobacillus reuteri DSM 17938
- Other: maltodextrin
- Other: Oil mix (medium chain triglycerides and sunflower oil)
|
Interventional |
Phase 4 |
- Andrea Garcia Contreras
- Hospital Civil Juan I. Menchaca
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in the composition of the microbiota (firmicutes, bifidobacteria and lactobacilli)
- change in consistency of feces
- change in potential of hydrogen (pH) of feces
- (and 2 more...)
|
40 |
All |
6 Months to 60 Months (Child) |
NCT03117322 |
0167/17 |
|
June 5, 2017 |
June 2018 |
July 2018 |
April 17, 2017 |
September 28, 2017 |
|
- Nuevo Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico
|
| 32 |
NCT03054506 |
Recruiting |
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation |
- Constipation
- Chronic Idiopathic Constipation
- Irritable Bowel Syndrome With Constipation
|
- Device: CSP01
- Device: Carboxymethylcellulose (CMC)
- Device: Placebo
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- Gelesis, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Colonic Transit Time (CTT)
- Spontaneous Bowel Movement (SBM) frequency rate
- Complete Spontaneous Bowel Movement (CSBM) frequency rate
- (and 10 more...)
|
53 |
All |
22 Years to 70 Years (Adult, Senior) |
NCT03054506 |
2016P001751 |
|
March 7, 2017 |
August 2018 |
November 2018 |
February 15, 2017 |
October 25, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 33 |
NCT02813616 |
Recruiting |
Factors Affecting Dissatisfaction to Treatments in Patients With Chronic Constipation and IBS With Constipation |
- Constipation
- Irritable Bowel Syndrome
|
|
Observational |
|
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of patients achieving a sustained improvement
- Factors associated with sustained improvement: Gender
- Factors associated with sustained improvement: Age
- (and 8 more...)
|
90 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02813616 |
SC-2016 |
|
February 2016 |
September 2017 |
December 2018 |
June 27, 2016 |
August 22, 2017 |
|
- IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
|
| 34 |
NCT03018613 |
Recruiting |
Fecal Microbiota Transplantation for Chronic Functional Constipation |
- Chronic Functional Constipation
- Intestinal Bacteria Flora Disturbance
- Fecal Microbiota Transplantation
|
- Other: Fecal Microbiota Transplantation
- Other: Normal Saline
|
Interventional |
Phase 1
Phase 2 |
- First Affiliated Hospital of Chengdu Medical College
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of adverse events complication rate in all patients in both groups
- Mean number of bowel movements per week
- Bristol stool scale
- (and 5 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03018613 |
FMT-CFC |
FMTFCFC |
July 2016 |
July 2018 |
July 2019 |
January 12, 2017 |
January 12, 2017 |
|
- IEC of Chengdu Medical College
Chendu, China
|
| 35 |
NCT02838797 |
Recruiting |
RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease |
- Parkinson's Disease
- Gastroparesis
- Constipation
|
- Drug: RQ-00000010
- Drug: Placebo
|
Interventional |
Phase 1 |
- Virginia Commonwealth University
- Michael J. Fox Foundation for Parkinson's Research
- RaQualia Pharma Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
- Gastric emptying
- Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses
- Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT02838797 |
HM20001657 |
RQ-10 |
June 2016 |
March 2019 |
March 2019 |
July 20, 2016 |
April 3, 2018 |
|
- VCU NOW Center
Henrico, Virginia, United States
|
| 36 |
NCT03030664 |
Recruiting |
Effect of L. Reuteri on Bowel Movements in Children (BIOWELL Study) |
|
- Dietary Supplement: L.reuteri
- Drug: Placebo
|
Interventional |
Not Applicable |
- Centre Hospitalier Intercommunal Creteil
- BioGaia AB
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in number of spontaneous bowel movements
- Total number of rescue medication during the intervention period
- number of subjects with 3 or more than 3 stools per week and without fecal retention at the last week of the intervention period
- (and 3 more...)
|
58 |
All |
6 Months to 4 Years (Child) |
NCT03030664 |
BIOWELL |
BIOWELL |
March 1, 2017 |
May 2019 |
September 2019 |
January 25, 2017 |
April 5, 2018 |
|
- CH Sud francilien
Corbeil-Essonnes, France - CHI Creteil
Créteil, France - Hôpital J. Monod - Pavillon Femme Mère Enfant - Le Havre
Le Havre, France - (and 6 more...)
|
| 37 |
NCT02246647 |
Recruiting |
Biomarkers for Intestinal Permeability in Patients With Constipation |
- Intestinal Diseases
- Irritable Bowel Syndrome
- Constipation
|
- Other: saccharides
- Procedure: esophagogastroduodenoscopy
- Procedure: flexible sigmoidoscopy
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- 8-24 hr cumulative excretion of mannitol.
|
36 |
All |
18 Years to 65 Years (Adult) |
NCT02246647 |
14-002382 |
|
September 2014 |
October 2016 |
October 2017 |
September 23, 2014 |
September 16, 2016 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 38 |
NCT03031301 |
Recruiting |
A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week |
|
- Device: Vibrant capsule
- Device: Sham capsule
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Complete Spontaneous Bowel Movement (CSBM) success rate, defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.
|
190 |
All |
22 Years and older (Adult, Senior) |
NCT03031301 |
240CLD |
|
February 1, 2017 |
July 2018 |
July 2018 |
January 25, 2017 |
January 12, 2018 |
|
- Avant Guntersville
Guntersville, Alabama, United States - Floridian Research Institute
Miami, Florida, United States
|
| 39 |
NCT02789111 |
Not yet recruiting |
Trial of Alvimopan in Major Spine Surgery |
|
- Drug: Alvimopan
- Drug: Placebo
|
Interventional |
Phase 4 |
- University of Virginia
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- time to first bowel movement
- time to resumption of PO intake
|
50 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02789111 |
18781 |
|
June 2016 |
December 2017 |
December 2017 |
June 2, 2016 |
June 2, 2016 |
|
- University of Virginia
Charlottesville, Virginia, United States
|
| 40 |
NCT02772692 |
Not yet recruiting |
Defecation Postures for Functional Consumption |
|
- Behavioral: Squatting pan
|
Interventional |
Not Applicable |
- Fourth Military Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Frequency of defecation
- Frequency of re-defecation after the first defecation
- Defecation time
- (and 2 more...)
|
600 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02772692 |
20160511 |
|
May 2016 |
January 2017 |
January 2017 |
May 13, 2016 |
May 13, 2016 |
|
|
| 41 |
NCT02837783 |
Recruiting |
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With IBS-C |
- Irritable Bowel Syndrome Characterized by Constipation
|
- Drug: Linaclotide
- Drug: Placebo
|
Interventional |
Phase 4 |
- Ironwood Pharmaceuticals, Inc.
- Manchester University NHS Foundation Trust
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean Change in Abdominal Girth (physical measure of bloating/distention)
- Change from Baseline in Abdominal Distension at Week 2
- Change from Baseline in Maximal Abdominal Distension at Week 4
- (and 3 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02837783 |
MCP-103-403 |
|
December 21, 2016 |
December 2018 |
March 2019 |
July 20, 2016 |
April 11, 2018 |
|
- Peter Whorwell
Wythenshawe, Manchester, United Kingdom
|
| 42 |
NCT03233100 |
Recruiting |
FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms |
- Constipation - Functional
- Depressive Symptoms
- Anxiety Symptoms
- Gut-Brain Disorders
|
|
Interventional |
Not Applicable |
- Jianfeng Gong
- Jinling Hospital, China
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- CSBMs per week
- HAMA
- HAMD
- (and 4 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03233100 |
STC-D-A-2017-FMT |
|
July 30, 2017 |
December 31, 2018 |
December 31, 2018 |
July 28, 2017 |
July 28, 2017 |
|
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
|
| 43 |
NCT03487640 |
Recruiting
New |
Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse |
- Constipation by Outlet Obstruction
|
- Procedure: TARMR
- Procedure: LARSC
|
Observational |
|
- Third Military Medical University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Wexner constipation score
- patients' satisfaction rate
- short period complications
- (and 2 more...)
|
8 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03487640 |
LarTARP |
|
January 8, 2018 |
January 8, 2020 |
December 31, 2020 |
April 4, 2018 |
April 4, 2018 |
|
- Weidong Tong
Yuzhong, Chongqing, China
|
| 44 |
NCT02813369 |
Recruiting |
Naloxegol Health Outcomes PASS |
- Opioid Induced Constipation
|
- Drug: naloxegol
- Drug: non-PAMORA laxative
|
Observational |
|
- Kyowa Kirin Pharmaceutical Development Ltd
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Presence (yes/no) of bowel perforation
- Presence (yes/no) of acute MI
- Presence (yes/no) of stroke
- (and 2 more...)
|
10000 |
All |
Child, Adult, Senior |
NCT02813369 |
D3820R00009 |
|
July 2016 |
December 2021 |
December 2021 |
June 27, 2016 |
March 7, 2018 |
|
- Research Site
Sutton, Surrey, United Kingdom
|
| 45 |
NCT02813356 |
Recruiting |
Naloxegol US PMR CV Safety |
- Opioid Induced Constipation
|
- Drug: naloxegol
- Drug: non-PAMORA
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- major adverse cardiovascular events
|
8800 |
All |
Child, Adult, Senior |
NCT02813356 |
D3820R00008
EUPAS18201 |
|
June 24, 2016 |
December 31, 2020 |
December 31, 2020 |
June 27, 2016 |
April 3, 2018 |
|
- Research Site
Wilmington, Delaware, United States - Research Site
Hines, Illinois, United States
|
| 46 |
NCT02813148 |
Recruiting |
Naloxegol Drug Utilization PASS |
- Opioid Induced Constipation
|
|
Observational |
|
- Kyowa Kirin Pharmaceutical Development Ltd
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- discontinuation
- Switching
- Augmentation
- (and 3 more...)
|
3000 |
All |
Child, Adult, Senior |
NCT02813148 |
D3820R00006 |
|
July 2016 |
December 2018 |
December 2018 |
June 24, 2016 |
March 7, 2018 |
|
- Research Site
Espoo, Finland - Research Site
Frankfurt am Main, Germany - Research Site
Sutton, United Kingdom
|
| 47 |
NCT03150212 |
Recruiting |
Effect of Saccharomyces Cerevisiae on the Improvement of Gastro-intestinal Disorders Associated to IBS With C Phenotype |
- Constipation-predominant Irritable Bowel Syndrome
|
- Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Abdominal pain/discomfort score rated with Likert scale (ranging from 0 to 7)
|
456 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03150212 |
2016-A01574-47 |
IBS-GO |
March 20, 2017 |
June 2019 |
June 2019 |
May 12, 2017 |
July 14, 2017 |
|
- General pratices
France, France - Eurofins Optimed
Gieres, France - Créabio Rhône Alpes
Givors, France - (and 2 more...)
|
| 48 |
NCT02812836 |
Not yet recruiting |
3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children |
|
|
Interventional |
Not Applicable |
- Medical University of Warsaw
- Medtronic
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.
- Bear down manoeuver pressure differential
- puborectalis muscle pressure
|
100 |
All |
5 Years to 18 Years (Child, Adult) |
NCT02812836 |
Banasiuk 2016B |
|
September 2016 |
September 2017 |
September 2017 |
June 24, 2016 |
June 24, 2016 |
|
- Department of Pediatric Gastroenterology and Nutrition
Warsaw, Poland
|
| 49 |
NCT02078323 |
Recruiting |
Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients |
- Irritable Bowel Syndrome With Constipation (IBS-C)
|
- Drug: Linaclotide
- Drug: Placebo
|
Interventional |
Not Applicable |
- Augusta University
- Forest Laboratories
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Other
|
- 1: Change from baseline in Prolongation and normalization of anal CEP and rectal CEP responses at 10 weeks.
- Change from Baseline in Prolongation and normalization of rectal MEP and anal MEP at 10 weeks.
|
45 |
All |
18 Years to 64 Years (Adult) |
NCT02078323 |
LNZ-IT-01 |
|
February 2014 |
August 2017 |
August 2017 |
March 5, 2014 |
June 27, 2017 |
|
- Augusta University
Augusta, Georgia, United States
|
| 50 |
NCT02977286 |
Recruiting |
Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids |
|
- Drug: Naloxegol Oral Tablet
- Drug: Placebo Oral Tablet
- Drug: Docusate Sodium 100 Mg oral capsule [Colace]
- (and 5 more...)
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Time to first spontaneous bowel movement (SBM) administration
- Time to first SBM
- ICU days without a SBM
- (and 14 more...)
|
36 |
All |
18 Years and older (Adult, Senior) |
NCT02977286 |
11200 |
|
November 2016 |
July 2018 |
July 2018 |
November 30, 2016 |
December 6, 2017 |
|
- Tufts Medical Center
Boston, Massachusetts, United States
|
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