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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT02047045
First received: January 23, 2014
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Constipation
Procedure: acupuncture
Drug: Prucalopride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Multi-center Noninferiority Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • the proportion of patients with mean CSBMs≥3 per week over the latter 6-week treatment [ Time Frame: over the latter 6-week treatment ] [ Designated as safety issue: No ]
    comparing the proportion of patients with mean CSBMs≥3 per week between treatment group and controlled group over the latter 6-week treatment.


Secondary Outcome Measures:
  • the proportion of patients with mean CSBMs≥3 per week over the 12-week and 24-week follow-ups [ Time Frame: over the 12-week follow-up, over the 24-week follow-up, over the 4-week follow-up, over the 8-week follow-up, and over the first 2-week treatment ] [ Designated as safety issue: No ]
    comparing the proportion of patients with mean CSBMs≥3 per week between treatment group and controlled group over the 12-week, 24-week follow-ups. The proportion over the 4-week, 8-week follow-ups, and the first 2-week treatment will be also evaluated at the same time.

  • the proportion of patients with an increase of one or more weekly mean CSBMs from baseline [ Time Frame: over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups ] [ Designated as safety issue: No ]
    Comparing the proportion of patients with an increase of one or more weekly average CSBMs as compared with the baseline number between treatment group and controlled group over the latter 6-week treatment, over the first 2-week treatment, and over the 4-week, 8-week, 12-week, 24-week follow-ups.

  • mean CSBMs per week and change from baseline in mean CSBMs per week [ Time Frame: baseline, over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups ] [ Designated as safety issue: No ]
    Comparing the mean CSBMs between treatment group and controlled group over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups. Observing the change of mean CSBMs per week over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups compared with baseline.

  • mean SBMs per week and change from baseline in mean SBMs per week [ Time Frame: baseline, over the latter 6-week, first 2-week treatments, and over the 4-week , 8-week, 12-week, 24-week follow-ups ] [ Designated as safety issue: No ]
    Comparing the mean SBMs between treatment group and controlled group over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups. Observing the change of mean SBMs per week over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups compared with baseline.

  • weekly mean stool character score and change from baseline in weekly mean stool character score [ Time Frame: baseline, over the latter 6-week treatment, and over the first 2-week treatment ] [ Designated as safety issue: No ]
    Comparing mean stool character score per week between treatment group and controlled group over the latter 6-week and first 2-week treatments. Observing the change from baseline in average stool character score over the latter 6-week and first 2-week treatments.

  • weekly mean defecating difficulty score and change from baseline in weekly mean defecating difficulty score [ Time Frame: baseline, over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups ] [ Designated as safety issue: No ]
    Comparing the mean defecating difficulty per week between treatment group and controlled group over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups. Observing the change in mean defecating difficulty score per week over the latter 6-week, first 2-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups compared with baseline.

  • the time of the first complete spontaneous bowel movement after treatment [ Time Frame: week 1-12 ] [ Designated as safety issue: No ]
    Measuring the time, which is counted by hours, from the first treatment of electro-acupuncture, or the first dose of prucalopride intake to the first patient's complete, spontaneous bowel movement.

  • PAC-QOL score and the change from baseline in PAC-QOL score [ Time Frame: over the first 4-week and the latter 4-week treatments ] [ Designated as safety issue: No ]
    Comparing the average PAC-QOL aggregate scores and the mean scores of four different dimensions between treatment group and controlled group over the first 4-week and latter 4-week treatments. Observing the change of them over the first 4-week and latter 4-week treatments compared with baseline.


Other Outcome Measures:
  • drug use [ Time Frame: baseline, over the first 2-week, latter 6-week treatments, and over the 4-week, 8-week, 12-week, 24-week follow-ups ] [ Designated as safety issue: No ]
    Recording the days or dose of drug use (bisacodyl and other enemas) per week.


Estimated Enrollment: 560
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electro-acupuncture
Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks.
Procedure: acupuncture
Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
Other Name: eletro-acupuncture
Active Comparator: Prucalopride
Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast
Drug: Prucalopride
Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 8 weeks.
Other Name: serotonin 5-HT(4) receptor agonist

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. meeting Rome Ⅲ criteria for diagnosing functional constipation;
  2. severe chronic constipation (two or fewer CSBMs per week for more than 3 months;
  3. the weekly mean CSBMs and SBMs are no more than 2 times during the 2-week baseline
  4. aged from 18 to 75 years old
  5. no use of drugs for constipation (emergency treatments should be excepted) during at least 2 weeks before enrollment; no acupuncture treatment for constipation in the previous 1 month; never joined any other trial in progress;
  6. volunteered to join this research and signed the informed consent

Exclusion Criteria:

  1. irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
  2. mushy stool or watery stool are showed more than once during baseline when defecating spontaneously without any laxative (Bristol stool type 6 or 7);
  3. history of pelvic floor dysfunction;
  4. taking medicine in progress which can induce constipation;
  5. severe hemorrhoid or anal fissure;
  6. constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, abdominal aortic aneurysm or hepatosplenomegaly, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
  7. women in gestation or lactation period;
  8. blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
  9. cardiac pacemaker carrier.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02047045

Contacts
Contact: Zhishun Liu, Ph.D 8610-010-88001124 liuzhishun@aliyun.com
Contact: Jiani Wu, Ph.D 8610-010-88001124 handsom_mars@126.com

Locations
China
Guang'anmen Hospital Recruiting
Beijing, China, 100053
Contact: Zhishun Liu, Ph.D    8610-010-88001124    liuzhishun@aliyun.com   
Contact: Jiani Wu, Ph.D    8610-010-88001124    handsom_mars@126.com   
Sub-Investigator: Jiani Wu, Ph.D         
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Chair: Zhishun Liu, Ph.D Guang'anmen Hospital, China Academy of Chinese Medical Sciences
  More Information

No publications provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guang'anmen Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02047045     History of Changes
Other Study ID Numbers: 2012BAI24B01SCC
Study First Received: January 23, 2014
Last Updated: April 18, 2014
Health Authority: China: Ethics Committee

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
severe chronic constipation
randomized controlled
electro-acupuncture
prucalopride

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014