A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT01881282
First received: June 14, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to compare the therapeutic effect and safety of compound carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of pain.


Condition Intervention Phase
Hemorrhoids
Drug: Carraghenates Cream
Drug: Mayinglong Musk Hemorrhoid Ointment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Clinical Research on Therapeutic Effect and Safety of Compound Carraghenates Cream Versus Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:
  • Pain Acting Time [ Time Frame: Day 1 up to Day 7 ] [ Designated as safety issue: No ]
    The time from the first administration of the drugs to the time when the participant feels that his (her) pain has been remitted remarkably will be assessed.

  • Pain Intensity Score at Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Pain intensity will be measured on an 11-point numeric rating scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates intense pain. Grade 1-4 represents mild pain, Grade 5-6 moderate pain, and Grade 7-10 serious pain. Higher score indicates worsening.

  • Pain Intensity Score at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Pain intensity will be measured on an 11-point numeric rating scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates intense pain. Grade 1-4 represents mild pain, Grade 5-6 moderate pain, and Grade 7-10 serious pain. Higher score indicates worsening.

  • Daily Duration of Symptoms [ Time Frame: Day 1 up to Day 7 ] [ Designated as safety issue: No ]
    The accumulated time of the onset of all symptoms in the same day will be assessed. The baseline value before the administration of the drugs is the accumulated time of the occurrence of all symptoms in the day prior to the visit.

  • Frequency of Defecation [ Time Frame: Day 1 up to Day 7 ] [ Designated as safety issue: No ]
    The daily frequency of defecation for the day prior to the visit and each day during the trial period will be assessed.

  • Participants' Satisfaction for the Treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Participants' will assess for the treatment satisfaction on numeric rating scale (NRS) ranging from 1 to 5, where 1= Very unsatisfactory; 2= Unsatisfactory; 3=General; 4= Satisfactory; 5= Very satisfactory.

  • Assessment of Other Symptoms and Signs Including Bleeding, Edema, Local Discomfort, and Prolapse [ Time Frame: Day 1 up to Day 7 ] [ Designated as safety issue: No ]
    Participants will assess these symptoms on a score range of 0 to 3 where 0=none for all symptoms and 3= "Blood jets while defecating, and the blood jetting stops after defecation" for bleeding, "serious edema" for edema, "severe" for local discomfort and "it is difficult or unable to return the prolapsed pile" for prolapse.


Enrollment: 123
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carraghenates Cream Drug: Carraghenates Cream
Carraghenates cream will be administered 3-4 gram (g) each time (one sixth of a piece) through anal canal, twice a day (once in the morning and once in the evening); for consecutive 6 days.
Active Comparator: Mayinglong Musk Hemorrhoid Ointment Drug: Mayinglong Musk Hemorrhoid Ointment
Mayinglong musk hemorrhoid ointment will be administered 2 g each time through anal canal, twice a day (once in the morning and once in the evening) for consecutive 6 days.

Detailed Description:

This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), controlled clinical trial and comparative study of safety and efficacy of compound carraghenates cream with Mayinglong musk hemorrhoid ointment in the treatment of hemorrhoids, especially regarding the relief of pain. Participants will be randomly assigned to either of the two treatment groups that are carraghenates cream (Titanoreine) group or Mayinglong musk hemorrhoid ointment group. The total duration of the study will be 1 Week (7 days). In carraghenates cream group, 3-4 gram (g) cream will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days and in the Mayinglong musk hemorrhoid ointment group, 2 g ointment will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days. Efficacy will be assessed by using Numeric Rating Scale (NRS) and participants' safety will be monitored throughout the trial.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who agree to participate in the current study
  • Participants having painful hemorrhoids (swollen veins in the lower part of the rectum or anus [external hemorrhoid, mixed hemorrhoid, etc.])
  • Participants who did not use other topical drugs to treat their hemorrhoids a day before the inclusion
  • Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period

Exclusion Criteria:

  • Participants having other anorectal diseases , such as anal fistula , anal cleft , perianal abscess , and anorectal occupied lesions etc
  • Participants having hypersensitive predisposition or hypersensitive to any of components of the study drugs
  • Female participants under pregnancy or during breastfeeding period
  • Participants who fail to accept the scheduled visits or are lost to the visits
  • Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or mental disorders
  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: NCT01881282

Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01881282     History of Changes
Other Study ID Numbers: CR002125, TITC-CHN-IIS-02
Study First Received: June 14, 2013
Last Updated: February 27, 2014
Health Authority: China: Ethics Committee

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Hemorrhoids
Carraghenates
Mayinglong Musk
Titanoreine

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014