Effect Comparison of Electro-acupuncture & Prucalopride for Severe Chronic

Status Completed

Clinical Trial Summary

This trial is primarily aimed to compare the effect and safety of electro-acupuncture and prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6 months? Then, assess the patients' acceptance of electro-acupuncture.

Clinical Trial Description

Study design: this trial is a multi-central randomized controlled trial which contains 14 centers. Random sequences will be generated by the clinical evaluating center of China Academy of Chinese Medical Sciences. Subjects are patients who have severe chronic constipation. Sample size evaluation: Sample size will be based on the proportion of patients having mean complete spontaneous bowel movements (CSBMs) no less than 3 times per week. The proportion is 31.67% in our phase I clinical trial by using electro-acupuncture, and 30.9% in another trial by using prucalopride.The total sample size is 560. Periods and primary outcome: participants will be assessed at baseline for 2 weeks, treated for 8 weeks, and followed up for 24 weeks. Primary outcome is the proportion of patients having mean CSBMs/week no less than 3 times over the latter 6-week treatment. Quality control: the study is a randomized controlled trial; participants were included strictly; evaluators and statisticians are blinded; quality control officers of 3 different levels will supervise this trial. Data management: this trial will use the Remote Dara Capture (RDC) system for data entering and Data Verification Plan (DVP) for data examining. Statistical analysis: Intention-To-Treat (ITT) analysis will be used in this study. One-sided test (non-inferiority) will be used for testing the primary outcomes; meanwhile, two-sided test will be used for evaluating other outcomes. A P value equal to or less than 0.05 is considered to indicate statistical significance. ;

Study Design

Related Conditions & MeSH terms

Constipation

Clinical Trial Details

NCT number	NCT02047045
Study type	Interventional
Source	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact
Status	Completed
Phase	N/A
Start date	April 2014
Completion date	May 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Recruiting	`NCT06292949` - Clinical Study of Resistant Starch in Improving Constipation	N/A
Recruiting	`NCT04132661` - MRI Assessment of Mode of Action of Bisacodyl, Single Dose	Phase 4
Terminated	`NCT02839889` - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)	Phase 4
Completed	`NCT02726295` - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study	Phase 4
Recruiting	`NCT02255747` - Anal Dilatation for Infants and Children With Constipation	N/A
Completed	`NCT02246647` - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed	`NCT01566409` - Maintenance Treatment for Children With Constipation	N/A
Completed	`NCT02863848` - Effect of Inulin-type Fructans on Constipated Children.	N/A
Completed	`NCT01695915` - Diurnal Variation in Rectal Diameter	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Completed	`NCT02658201` - Ultrafast MRI Imaging to Exclude Constipation	N/A
Completed	`NCT01438567` - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy	Phase 3
Completed	`NCT01474499` - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation	Phase 3
Completed	`NCT01411501` - Efficacy and Safety of Acupuncture for Functional Constipation	Phase 3
Completed	`NCT00931853` - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).	Phase 3
Completed	`NCT01170039` - The Effectiveness of Lubiprostone in Constipated Diabetics	Phase 4
Active, not recruiting	`NCT02442115` - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed	`NCT00994851` - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.	Phase 3
Terminated	`NCT01003249` - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms