Fissure in AnoPhase 4NCT02419534
Pediatrics Anal Fissures Treatment With Polyethylene Glycol
A Phase 4 study testing Polyethylene glycol and Polyethylene glycol with Diltiazem in people with Fissure in Ano, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
To evaluate whether effectively treating anal fissure-associated constipation using oral PEG alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies have shown the topical agent are more effective in treating anal fissure when combined with less effective laxatives Read more about this study
- Who is it for?
- Ages 1 minute to 13 years
- Conditions the study is for
- Fissure in Ano
- What is being tested?
- Polyethylene glycol and Polyethylene glycol with Diltiazem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Painful defecation with visible anal fissure
- Symptoms for 2 weeks
- Children less than 14 years of age
Who cannot join
- Previous surgeries
- Chronic illness affecting the rectum or perianal area
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
Al-Jazaeri, MD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
College of medicine, king saud university
Riyadh, Nejd Province - Central
Ayman Al-Jazaeri, (966)-5-65994455
About this study
Official title: Randomized Controlled Trial Comparing the Efficacy of Polyethylene Glycol Alone and Polyethylene Glycol Combined With Topical Diltiazem in Treating Anal fissure in Children
To evaluate whether effectively treating anal fissure-associated constipation using oral PEG alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies have shown the topical agent are more effective in treating anal fissure when combined with less effective laxatives
Read the detailed description
Anal fissure (AF) is common among children attending pediatric and surgery clinics and is frequently associated with painful defecation, stool withholding and constipation which affect 1%-30% of the pediatric population. Constipated children consume low fiber diets, come from lower socioeconomic families and tend to be obese. The reason why anal fissure develops is still largely unclear, however the pathogenesis points to an initial anal trauma cause by the hard stool leading to anal sphincter hypertonia or spasm which cause local ischemia and non-healing ulcer. It is not clear why the posterior anal canal is the most affected part by the local anal ischemia.
Current medical therapy for chronic anal fissure focuses on alleviating the two main pathologies by using anal sphincter relaxing topical ointments and laxative to treat associated constipation. The classical text book described treatment of AF focus on increasing fiber intake to treat the underlying constipation. Jensen et al, has found that treating the first episode of anal fissure with bran is more effective than local anesthetic or steroids. The American Society of Colon and Rectal Surgeons practice parameters suggest that increase in fluid and fiber ingestion, use of sitz baths, and if necessary use of stool softeners are safe have few side effects and should be the initial therapy for all patients with anal fissure.
There have been many recent randomized trials describing the effectiveness of Nitroglycerin (NTG), Botulinum toxin injection or the topical calcium channel blockers such as Diltiazem (DTZ) in adult and pediatric. A systematic review of the available randomized trials of these agents has shown that topical agents are marginally better than placebo [15]. Furthermore, in most trials that have demonstrated the effectiveness of topical agents laxatives usage was either not well controlled or lactulose was the main agent used. In children, many recent randomized trials have demonstrated the superior effectiveness of PEG over lactulose consequently; we think that treating AF with PEG is likely to improve the success rate and lead to persistent log-term fissure healing. Most adults and pediatric RCTs that have demonstrated the effectiveness of topical agents in healing AF, have focused on comparing various topical agents to placebo in treating AF, however the effectiveness in comparison to placebo has never been demonstrated in patients how are placed on more effective laxative such as PEG. We hypothesize that replacing lactulose with a more effective laxative such PEG as a sole agent to treat AF can eliminate the effectiveness and therefore the need to add topical sphincter relaxing agent such DTZ or NTG. Laxative-only treatment is likely to be more convenient and more cost-effective.
- Conditions
- Fissure in Ano
- Being tested
- Polyethylene glycol, Polyethylene glycol with Diltiazem
- Keywords
- Pediatric, fissure in ano
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycolDrug
Also called Movicol
Laxative to treat constipation
Polyethylene glycol with DiltiazemDrug
Also called Movicol + Diltiazem
Laxative and topical calcium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol | Active comparator | In our study parents will be asked to start at 1g per day if they are less than 1 year of age and 2g per day in divided doses if they are older and will be asked to titrate the does according to the response up to the a maximum does of .5g/kg/day. In titrating the dose parent will be asked to increase the dose every 2 days until the child pass one normal BM per day without significant efforts. They should titrate down or hold treatment if the child developed lose BM or diarrhea. Caregiver will be asked to use placebo ointment by applying 5mm on fingertip to the anal verge area twice a day for the duration of the study. Receives: Drug: Polyethylene glycol |
| Polyethylene glycol with Diltiazem | Active comparator | Parents will be instructed to apply 5 mm of ointment on a fingertip at the anal verge twice daily for the duration of the study Receives: Drug: Polyethylene glycol with Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with healed anal fissure as detected by clinical physical exam
Measured: up to 8 weeks
Secondary outcomes (5)
Number cases with painless bowel movement detected during clinical visits or phone interviews
Measured: at 2,4 and 8 weeks
Number of individuals with minimal or no straining during bowel movement detected during clinical visits or phone interviews
Measured: at 2, 4, and 8 weeks
Number of cases that are passing soft bowel movements detected during clinical visits or phone interviews
Measured: at 2, 4, and 8 weeks
Number of cases who are passing > 3 watery bowel movement (Diarrhea) detected during clinical visits or phone interviews
Measured: at 2, 4, and 8 weeks
Compliance (number of cases who are taking the PEG and/or Diltiazem Ointment) as detected during clinical visits or phone interviews
Measured: 2, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Fissure in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Aljazaeri, King Saud University
- Investigators
- Ayman Al-Jazaeri, Principal investigator, Associate Professor & Consultant of Pediatric,Medical College, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419534
- Sponsor's protocol ID
- 14/4293
- Status last verified
- Feb 2016
- First submitted
- 2 Apr 2015
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
PubMed 21382575Sonmez K, Demirogullari B, Ekingen G, Turkyilmaz Z, Karabulut R, Basaklar AC, Kale N. Randomized, placebo-controlled treatment of anal fissure by lidocaine, EMLA, and GTN in children. J Pediatr Surg. 2002 Sep;37(9):1313-6. doi: 10.1053/jpsu.2002.34997.
PubMed 12194122Farouk R, Duthie GS, MacGregor AB, Bartolo DC. Sustained internal sphincter hypertonia in patients with chronic anal fissure. Dis Colon Rectum. 1994 May;37(5):424-9. doi: 10.1007/BF02076185.
PubMed 8181401Poh A, Tan KY, Seow-Choen F. Innovations in chronic anal fissure treatment: A systematic review. World J Gastrointest Surg. 2010 Jul 27;2(7):231-41. doi: 10.4240/wjgs.v2.i7.231.
PubMed 21160880Schouten WR, Briel JW, Auwerda JJ. Relationship between anal pressure and anodermal blood flow. The vascular pathogenesis of anal fissures. Dis Colon Rectum. 1994 Jul;37(7):664-9. doi: 10.1007/BF02054409.
PubMed 8026232Jensen SL. Treatment of first episodes of acute anal fissure: prospective randomised study of lignocaine ointment versus hydrocortisone ointment or warm sitz baths plus bran. Br Med J (Clin Res Ed). 1986 May 3;292(6529):1167-9. doi: 10.1136/bmj.292.6529.1167.
PubMed 3011180Perry WB, Dykes SL, Buie WD, Rafferty JF; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of anal fissures (3rd revision). Dis Colon Rectum. 2010 Aug;53(8):1110-5. doi: 10.1007/DCR.0b013e3181e23dfe. No abstract available.
PubMed 20628272Samim M, Twigt B, Stoker L, Pronk A. Topical diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure: a double-blind randomized clinical trial. Ann Surg. 2012 Jan;255(1):18-22. doi: 10.1097/SLA.0b013e318225178a.
PubMed 21685792Ala S, Saeedi M, Hadianamrei R, Ghorbanian A. Topical diltiazem vs. topical glyceril trinitrate in the treatment of chronic anal fissure: a prospective, randomized, double-blind trial. Acta Gastroenterol Belg. 2012 Dec;75(4):438-42.
PubMed 23402088Cevik M, Boleken ME, Koruk I, Ocal S, Balcioglu ME, Aydinoglu A, Karadag CA. A prospective, randomized, double-blind study comparing the efficacy of diltiazem, glyceryl trinitrate, and lidocaine for the treatment of anal fissure in children. Pediatr Surg Int. 2012 Apr;28(4):411-6. doi: 10.1007/s00383-011-3048-4. Epub 2012 Jan 3.
PubMed 22212494Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont GL, Lloyd DA. Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Arch Dis Child. 2001 Nov;85(5):404-7. doi: 10.1136/adc.85.5.404.
PubMed 11668104Tander B, Guven A, Demirbag S, Ozkan Y, Ozturk H, Cetinkursun S. A prospective, randomized, double-blind, placebo-controlled trial of glyceryl-trinitrate ointment in the treatment of children with anal fissure. J Pediatr Surg. 1999 Dec;34(12):1810-2. doi: 10.1016/s0022-3468(99)90318-4.
PubMed 10626860Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
PubMed 22336789Gremse DA, Hixon J, Crutchfield A. Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Clin Pediatr (Phila). 2002 May;41(4):225-9. doi: 10.1177/000992280204100405.
PubMed 12041718Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoit S, Benssoussan A, Boussioux JL, Boyer P, Brunet E, Delorme J, Francois-Cecchin S, Gottrand F, Grassart M, Hadji S, Kalidjian A, Languepin J, Leissler C, Lejay D, Livon D, Lopez JP, Mougenot JF, Risse JC, Rizk C, Roumaneix D, Schirrer J, Thoron B, Kalach N. Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):625-33. doi: 10.1097/01.mpg.0000181188.01887.78.
PubMed 16254521
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Efficacy of Polyethylene Glycol Alone and Polyethylene Glycol Combined With Topical Diltiazem in Treating Anal fissure in Children
- ClinicalTrials.gov ID
- NCT02419534
- Acronym / sponsor ID
- 14/4293
- Conditions
- Fissure in Ano
- Keywords
- Pediatric, fissure in ano
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether effectively treating anal fissure-associated constipation using oral PEG alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies have shown the topical agent are more effective in treating anal fissure when combined with less effective laxatives
Detailed description
Anal fissure (AF) is common among children attending pediatric and surgery clinics and is frequently associated with painful defecation, stool withholding and constipation which affect 1%-30% of the pediatric population. Constipated children consume low fiber diets, come from lower socioeconomic families and tend to be obese. The reason why anal fissure develops is still largely unclear, however the pathogenesis points to an initial anal trauma cause by the hard stool leading to anal sphincter hypertonia or spasm which cause local ischemia and non-healing ulcer. It is not clear why the posterior anal canal is the most affected part by the local anal ischemia.
Current medical therapy for chronic anal fissure focuses on alleviating the two main pathologies by using anal sphincter relaxing topical ointments and laxative to treat associated constipation. The classical text book described treatment of AF focus on increasing fiber intake to treat the underlying constipation. Jensen et al, has found that treating the first episode of anal fissure with bran is more effective than local anesthetic or steroids. The American Society of Colon and Rectal Surgeons practice parameters suggest that increase in fluid and fiber ingestion, use of sitz baths, and if necessary use of stool softeners are safe have few side effects and should be the initial therapy for all patients with anal fissure.
There have been many recent randomized trials describing the effectiveness of Nitroglycerin (NTG), Botulinum toxin injection or the topical calcium channel blockers such as Diltiazem (DTZ) in adult and pediatric. A systematic review of the available randomized trials of these agents has shown that topical agents are marginally better than placebo [15]. Furthermore, in most trials that have demonstrated the effectiveness of topical agents laxatives usage was either not well controlled or lactulose was the main agent used. In children, many recent randomized trials have demonstrated the superior effectiveness of PEG over lactulose consequently; we think that treating AF with PEG is likely to improve the success rate and lead to persistent log-term fissure healing. Most adults and pediatric RCTs that have demonstrated the effectiveness of topical agents in healing AF, have focused on comparing various topical agents to placebo in treating AF, however the effectiveness in comparison to placebo has never been demonstrated in patients how are placed on more effective laxative such as PEG. We hypothesize that replacing lactulose with a more effective laxative such PEG as a sole agent to treat AF can eliminate the effectiveness and therefore the need to add topical sphincter relaxing agent such DTZ or NTG. Laxative-only treatment is likely to be more convenient and more cost-effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol | Active comparator | Drug: Polyethylene glycolIn our study parents will be asked to start at 1g per day if they are less than 1 year of age and 2g per day in divided doses if they are older and will be asked to titrate the does according to the response up to the a maximum does of .5g/kg/day. In titrating the dose parent will be asked to increase the dose every 2 days until the child pass one normal BM per day without significant efforts. They should titrate down or hold treatment if the child developed lose BM or diarrhea. Caregiver will be asked to use placebo ointment by applying 5mm on fingertip to the anal verge area twice a day for the duration of the study. |
| Polyethylene glycol with Diltiazem | Active comparator | Drug: Polyethylene glycol with DiltiazemParents will be instructed to apply 5 mm of ointment on a fingertip at the anal verge twice daily for the duration of the study |
Who may qualify
- Ages
- 1 minute to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Painful defecation with visible anal fissure
- Symptoms for 2 weeks
- Children less than 14 years of age
Key exclusion criteria (3 listed)
- Previous surgeries
- Chronic illness affecting the rectum or perianal area
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycolAlso: MovicolLaxative to treat constipation | Drug | Polyethylene glycol |
| Polyethylene glycol with DiltiazemAlso: Movicol + DiltiazemLaxative and topical calcium channel blocker | Drug | Polyethylene glycol with Diltiazem |
Primary outcome
Number of cases with healed anal fissure as detected by clinical physical exam
Time frame: up to 8 weeks
5 secondary outcomes
Number cases with painless bowel movement detected during clinical visits or phone interviews
Time frame: at 2,4 and 8 weeks
Number of individuals with minimal or no straining during bowel movement detected during clinical visits or phone interviews
Time frame: at 2, 4, and 8 weeks
Number of cases that are passing soft bowel movements detected during clinical visits or phone interviews
Time frame: at 2, 4, and 8 weeks
Number of cases who are passing > 3 watery bowel movement (Diarrhea) detected during clinical visits or phone interviews
Time frame: at 2, 4, and 8 weeks
Compliance (number of cases who are taking the PEG and/or Diltiazem Ointment) as detected during clinical visits or phone interviews
Time frame: 2, 4, and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Results publication: PubMed 21382575Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
- Results publication: PubMed 12194122Sonmez K, Demirogullari B, Ekingen G, Turkyilmaz Z, Karabulut R, Basaklar AC, Kale N. Randomized, placebo-controlled treatment of anal fissure by lidocaine, EMLA, and GTN in children. J Pediatr Surg. 2002 Sep;37(9):1313-6. doi: 10.1053/jpsu.2002.34997.
- Results publication: PubMed 8181401Farouk R, Duthie GS, MacGregor AB, Bartolo DC. Sustained internal sphincter hypertonia in patients with chronic anal fissure. Dis Colon Rectum. 1994 May;37(5):424-9. doi: 10.1007/BF02076185.
- Results publication: PubMed 21160880Poh A, Tan KY, Seow-Choen F. Innovations in chronic anal fissure treatment: A systematic review. World J Gastrointest Surg. 2010 Jul 27;2(7):231-41. doi: 10.4240/wjgs.v2.i7.231.
- Results publication: PubMed 8026232Schouten WR, Briel JW, Auwerda JJ. Relationship between anal pressure and anodermal blood flow. The vascular pathogenesis of anal fissures. Dis Colon Rectum. 1994 Jul;37(7):664-9. doi: 10.1007/BF02054409.
- Results publication: PubMed 3011180Jensen SL. Treatment of first episodes of acute anal fissure: prospective randomised study of lignocaine ointment versus hydrocortisone ointment or warm sitz baths plus bran. Br Med J (Clin Res Ed). 1986 May 3;292(6529):1167-9. doi: 10.1136/bmj.292.6529.1167.
- Results publication: PubMed 20628272Perry WB, Dykes SL, Buie WD, Rafferty JF; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of anal fissures (3rd revision). Dis Colon Rectum. 2010 Aug;53(8):1110-5. doi: 10.1007/DCR.0b013e3181e23dfe. No abstract available.
- Results publication: PubMed 21685792Samim M, Twigt B, Stoker L, Pronk A. Topical diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure: a double-blind randomized clinical trial. Ann Surg. 2012 Jan;255(1):18-22. doi: 10.1097/SLA.0b013e318225178a.
- Results publication: PubMed 23402088Ala S, Saeedi M, Hadianamrei R, Ghorbanian A. Topical diltiazem vs. topical glyceril trinitrate in the treatment of chronic anal fissure: a prospective, randomized, double-blind trial. Acta Gastroenterol Belg. 2012 Dec;75(4):438-42.
- Results publication: PubMed 22212494Cevik M, Boleken ME, Koruk I, Ocal S, Balcioglu ME, Aydinoglu A, Karadag CA. A prospective, randomized, double-blind study comparing the efficacy of diltiazem, glyceryl trinitrate, and lidocaine for the treatment of anal fissure in children. Pediatr Surg Int. 2012 Apr;28(4):411-6. doi: 10.1007/s00383-011-3048-4. Epub 2012 Jan 3.
- Results publication: PubMed 11668104Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont GL, Lloyd DA. Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Arch Dis Child. 2001 Nov;85(5):404-7. doi: 10.1136/adc.85.5.404.
- Results publication: PubMed 10626860Tander B, Guven A, Demirbag S, Ozkan Y, Ozturk H, Cetinkursun S. A prospective, randomized, double-blind, placebo-controlled trial of glyceryl-trinitrate ointment in the treatment of children with anal fissure. J Pediatr Surg. 1999 Dec;34(12):1810-2. doi: 10.1016/s0022-3468(99)90318-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Al-Jazaeri, MD contact
Ayman Al-Jazaeri principal investigator
Associate Professor & Consultant of Pediatric,Medical College, King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene glycol and Polyethylene glycol with Diltiazem in people with Fissure in Ano, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Al-Jazaeri, MD ((966)-5-65994455, aljazaeri@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases with healed anal fissure as detected by clinical physical exam (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419534, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.