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Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

Primary Purpose

Headache, Fasting, Fasting Headache

Status

Completed

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Etoricoxib

Placebo

About this trial

This is an interventional prevention trial for Headache focused on measuring Headache, Fasting, Fasting Headache, Ramadan, Ramadan Headache, Yom Kippur, Yom Kippur Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 18 -65.
Patients will be enrolled if they declared that they intended to complete the dawn to dusk Ramadan fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)
Patient states that he/she typically suffered from headache during fasting in the past.

Exclusion Criteria:

Patients with a history of severe cardiovascular disease, diabetes, asthma, COPD, hypertension, or a history of bleeding, particularly in the gastrointestinal tract
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
Pregnant or lactating patients. Sexually active women of childbearing age will be included only if using birth control
Severe hepatic dysfunction
Estimated renal creatinine clearance <30 ml/min
History of peptic ulcer, erosive gastritis, esophagitis or inflammatory bowel disease
Congestive heart failure
Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
Cancer or any other malignant disease
History of medication overuse. Overuse of analgesics or antimigraine drugs according to the IHS criteria (chapter 8)

Sites / Locations

Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Etoricoxib First

Etoricoxib Second

Arm Description

This arm will receive etoricoxib for six days, followed by placebo for eight days.

This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.

Outcomes

Primary Outcome Measures

Headache

The subjects will be asked to fill out a daily 'headache diary' at the end of the fast. They will be asked if they had a headache on that day, and if so its severity. We will then compare the number of subjects having a headache on each day and total number of 'headache days' between the groups.

Secondary Outcome Measures

Severity of Headache

We will ask the subject if they had a headache on a given day to rate its severity. We will then compare the severity of headache between groups.

Overall ease of fast

We will ask subjects to rate the ease of their fast on a daily basis on a 5 point scale and will compare general ease of fast between the groups.

Side effects and other symptoms

We will ask subjects to record other symptoms or side effects they had during the fast including nausea, abdominal pain, photophobia, difficulty breathing or other.

Full Information

NCT ID

NCT01148303

First Posted

June 17, 2010

Last Updated

March 7, 2011

Sponsor

Hartford Hospital

Collaborators

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01148303

Brief Title

Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

Official Title

Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hartford Hospital

Collaborators

Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators intend to study whether the use of the pain medication etoricoxib (Arcoxia) taken just before the Ramadan fast will prevent or lessen headache that some people get while fasting. The investigators hypothesize that etoricoxib will reduce the number of people getting headache, more than placebo. The investigators will do this by giving participants in the study either real medication or placebo (sugar pill) and comparing the results. The investigators will study this over two weeks. The first week one group will get the medicine and the other the placebo. The second the groups will switch. Neither the subjects nor the investigators will know who is in which group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Fasting, Fasting Headache, Ramadan Headache

Keywords

Headache, Fasting, Fasting Headache, Ramadan, Ramadan Headache, Yom Kippur, Yom Kippur Headache

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Etoricoxib First

Arm Type

Experimental

Arm Description

This arm will receive etoricoxib for six days, followed by placebo for eight days.

Arm Title

Etoricoxib Second

Arm Type

Experimental

Arm Description

This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.

Intervention Type

Drug

Intervention Name(s)

Etoricoxib

Other Intervention Name(s)

arcoxia

Intervention Description

Subjects will take etoricoxib 90mg by mouth just before the start of the daily fast. This will be for six days. After this they will receive placebo for eight days.

Intervention Type

Drug

Intervention Name(s)

Etoricoxib

Other Intervention Name(s)

Arcoxia

Intervention Description

This arm will receive placebo just before their fast for eight days. After this they will receive etoricoxib 90mg just before their daily fast for the next six days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Headache

Description

Time Frame

Two weeks

Secondary Outcome Measure Information:

Title

Severity of Headache

Description

We will ask the subject if they had a headache on a given day to rate its severity. We will then compare the severity of headache between groups.

Time Frame

Two weeks

Title

Overall ease of fast

Description

We will ask subjects to rate the ease of their fast on a daily basis on a 5 point scale and will compare general ease of fast between the groups.

Time Frame

Two weeks

Title

Side effects and other symptoms

Description

We will ask subjects to record other symptoms or side effects they had during the fast including nausea, abdominal pain, photophobia, difficulty breathing or other.

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 -65. Patients will be enrolled if they declared that they intended to complete the dawn to dusk Ramadan fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.) Patient states that he/she typically suffered from headache during fasting in the past. Exclusion Criteria: Patients with a history of severe cardiovascular disease, diabetes, asthma, COPD, hypertension, or a history of bleeding, particularly in the gastrointestinal tract Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors Pregnant or lactating patients. Sexually active women of childbearing age will be included only if using birth control Severe hepatic dysfunction Estimated renal creatinine clearance <30 ml/min History of peptic ulcer, erosive gastritis, esophagitis or inflammatory bowel disease Congestive heart failure Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease Cancer or any other malignant disease History of medication overuse. Overuse of analgesics or antimigraine drugs according to the IHS criteria (chapter 8)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naim Shehadeh, MD

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zev Wimpfheimer, MD

Organizational Affiliation

Shaare Zedek Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

17115981

Citation

Drescher MJ, Elstein Y. Prophylactic COX 2 inhibitor: an end to the Yom Kippur headache. Headache. 2006 Nov-Dec;46(10):1487-91. doi: 10.1111/j.1526-4610.2006.00609.x.

Results Reference

background

PubMed Identifier

20039959

Citation

Drescher MJ, Alpert EA, Zalut T, Torgovicky R, Wimpfheimer Z. Prophylactic etoricoxib is effective in preventing Yom Kippur headache: a placebo-controlled double-blind and randomized trial of prophylaxis for ritual fasting headache. Headache. 2010 Sep;50(8):1328-34. doi: 10.1111/j.1526-4610.2009.01587.x. Epub 2009 Dec 21.

Results Reference

background

PubMed Identifier

16033610

Citation

Topacoglu H, Karcioglu O, Yuruktumen A, Kiran S, Cimrin AH, Ozucelik DN, Sarikaya S, Soysal S, Turpcu U, Bozkurt S. Impact of Ramadan on demographics and frequencies of disease-related visits in the emergency department. Int J Clin Pract. 2005 Aug;59(8):900-5. doi: 10.1111/j.1742-1241.2005.00460.x.

Results Reference

background

PubMed Identifier

11279933

Citation

Awada A, al Jumah M. The first-of-Ramadan headache. Headache. 1999 Jul-Aug;39(7):490-3. doi: 10.1046/j.1526-4610.1999.3907490.x.

Results Reference

background

PubMed Identifier

10862316

Citation

Shah PA, Nafee A. Clinical profile of headache and cranial neuralgias. J Assoc Physicians India. 1999 Nov;47(11):1072-5.

Results Reference

background

PubMed Identifier

21848948

Citation

Drescher MJ, Wimpfheimer Z, Abu Khalef S, Gammaitoni A, Shehadeh N, Torgovicky R. Prophylactic etoricoxib is effective in preventing "first of Ramadan" headache: a placebo-controlled double-blind and randomized trial of prophylactic etoricoxib for ritual fasting headache. Headache. 2012 Apr;52(4):573-81. doi: 10.1111/j.1526-4610.2011.01993.x. Epub 2011 Aug 16.

Results Reference

derived

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Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

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