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

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ClinicalTrials.gov Identifier: NCT01881282
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hemorrhoids Drug: Carraghenates Cream Drug: Mayinglong Musk Hemorrhoid Ointment Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
Drug Information available for: Musks

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain Acting Time [ Time Frame: Day 1 up to Day 7 ]
    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.

  2. Pain Intensity Score at Day 4 [ Time Frame: Day 4 ]
    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.

  3. Pain Intensity Score at Day 7 [ Time Frame: Day 7 ]
    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.

  4. Daily Duration of Symptoms [ Time Frame: Day 1 up to Day 7 ]
    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.

  5. Frequency of Defecation [ Time Frame: Day 1 up to Day 7 ]
    The daily frequency of defecation for the day prior to the visit and each day during the trial period will be assessed.

  6. Participants' Satisfaction for the Treatment [ Time Frame: Day 7 ]
    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.

  7. Assessment of Other Symptoms and Signs Including Bleeding, Edema, Local Discomfort, and Prolapse [ Time Frame: Day 1 up to Day 7 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881282


Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research and Development LLC Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01881282     History of Changes
Other Study ID Numbers: CR002125
TITC-CHN-IIS-02
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Hemorrhoids
Carraghenates
Mayinglong Musk
Titanoreine
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases